Needleless connector with antimicrobial properties

ABSTRACT

A needleless connector and methods for preventing microbial ingress in medical device connections are disclosed. Various examples provide a needleless connector including a male luer having a recessed distal tip surface containing a water-soluble antimicrobial composition. Further examples include a trap for retaining antimicrobial composition. As the needleless connector is inserted into a female connector, a tapered surface distal edge acts to push microorganisms, while the distal tip surface is configured to leave microorganisms undisturbed. After insertion of the needleless connector, microorganisms present on the female luer surface are biased to reside in the recess region. The recess, trap, and antimicrobial composition are configured to facilitate a long-lasting supply of antimicrobial solution within the fluid-filled recess, at the same time confining the antimicrobial solution inside the recess. This produces a high concentration of antimicrobial solution for an extended time, killing microbes, stopping microbial ingress, and preventing infections in patients.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.62/756,967, filed Nov. 7, 2018; U.S. patent application Ser. No.16/404,378, filed May 6, 2019; and U.S. patent application Ser. No.16/444,486, filed Jun. 18, 2019, the contents of each of which areherein incorporated by reference in their entirety.

FIELD

The present disclosure relates to medical devices, systems, and methodsfor killing infection-causing organisms and providing in-situantimicrobial properties.

BACKGROUND

Infusion devices, such as catheters and on-catheter devices, arecommonly used in providing modern medical care to patients. For example,catheters such as hemodialysis catheters, peritoneal dialysis catheters,peripherally inserted central catheters, midline catheters and drainagecatheters are all commonly used in providing modern medical care topatients. Other infusion devices used in providing medical care includeneedleless connectors, intravenous (IV) administration sets, peritonealdialysis lines, transfer sets, syringes, valves and filters.

These infusion devices are useful for treating various medicalconditions. For example, peritoneal catheters allow patients with renaldisease to have waste and fluid removed from their bodies. Thus,catheters and other infusion devices make critical medical care possibleand are often essential to providing improved health care outcomes.

However, long-term use of catheters has a serious drawback in that asignificant percentage of catheters fail due to infection, resulting inelevated mortality rates and significantly increased healthcare costsassociated with treatment. Furthermore, infections are a leading causeof death in the United States, and many of those infections areattributable to infusion devices. The mortality rate associated withsuch infections is considerable. Therefore, a need exists for a mannerto reduce infections relating from the use of infusion devices.

SUMMARY

Infection-causing organisms are ever present in the environment; theylive on patients' skin and can survive and be transmitted in air andwater. Conventional medical device connectors and caps, such as male andfemale connectors with tapered luers, contain a threaded region alongwith a tapered sealing region, such as an overlapping sealing region ofthe tapered portions of male and female connectors. The overlappingsealing regions seal fluid inside the medical device and keep air andorganisms out. However, our testing shows that organisms can stillmigrate through the threaded region and penetrate a portion of the wayinto the sealing region. This results in organisms being present alongthe walls of the tapered portions of the male and female luers within athin interstitial space of the sealing region. When the male and femaleconnectors are separated from one another, some organisms can remain onthe walls of the male and female connectors, including on taperedportions of male luer and female luer of the male and female connectorsthat previously formed a seal. The next time a connection is made, someof the organisms on the wall of the female luer can be pushed past thesealing surface and into the fluid path (during insertion of the maleluer into the female luer). Once organisms are in the fluid path theycan multiply, spread, and cause an infection.

The walls of the male luer and female luer are typically tapered, or atleast partially tapered, and may also become contaminated by airborneorganisms landing on the surface or through touch contamination. Uponinserting the male luer into the female luer the organisms can be pushedinto the fluid path where they can also multiply, spread, and cause aninfection.

A catheter and other infusion devices are generally a tubularconstruction, thus catheters can be characterized as a “medical tube”.Similarly, other infusion devices can also be characterized as “medicaltubes.”

In certain aspects of the subject matter described herein, the distalend of the male luer, as well as intermediate portions (portions betweenthe distal and proximal ends) of the male luer, contain an antimicrobialcomposition. As used herein, the terms “proximal end” and “distal end”are used to refer to the relative positions on an article. With regardto a catheter, for example, the proximal end is the end closest to aperson servicing the catheter female connector, while the distal end isclosest to a patient. For example, the distal end of a hemodialysiscatheter will be inside a patient, while the proximal end will beoutside the patient and have a female luer on a female connector.Similarly, the proximal end of a male cap containing a male luer will beoutside of the female connector when coupled to the female connector,while the distal end of the male cap will be inside the female connectorwhen coupled to the female connector. As will be discussed later, FIGS.2 and 3A show directional arrows depicting the distal direction and theproximal direction (an intermediate location would be between the distaland proximal directions). FIG. 3A further shows a male cap 30 with theproximal and distal ends of the cap labeled. Thus “proximal” and“distal” are relative terms, showing the position relative to thepatient and ends of a device.

The present disclosure is directed, in part, to infusion devicescomprising a coupling, the coupling typically comprising both a maleconnector or cap and a female connector. In certain embodiments, themale connector will form a fluid tight seal with a female connector thatcomplies with International Standard ISO 80369-7 Connectors forintravascular or hypodermic applications.

As used herein, the term “female connector” is used to refer to portionsof an infusion device containing a female connector, and the femaleconnector generally includes a truncated conical taper referred toherein as the “female luer”. The truncated conical taper forming thefemale luer typically has a tapered surface. The female connector alsoincludes immediately surrounding elements, such as a threaded outerportion. The term “female connector” as used herein is also sometimesreferred to interchangeably in the medical field as a “femaleconnector”, “adapter”, “hub”, and “fitting” when describing an elementcontaining a female luer. As used herein, the terms “male connector” and“male cap” are used to refer to connectors having a sealing extensioncalled a male luer, and this male luer generally has a tapered surface(although in some implementations only parts of that male luer will betapered). A male connector has a fluid flow path through it (along itsaxis), while a male cap is sealed and does not have a fluid flow paththrough it. Thus, a male connector is meant to allow fluid flow throughit while a male cap is meant to form a fluid-tight seal and stop fluidflow within a catheter. In many implementations the male connector andcap will have similar or identical internal geometries, other than acentral conduit for fluid flow, and in this disclosure the term“connector” is therefore sometimes used to refer to both a connectorwith a fluid path through it and a cap that does not have a fluid flowpath through it. When describing a specific embodiment, the term“connector” or “cap” may be used to describe a specific embodiment, butthis is generally not meant to be limiting.

When describing a mated pair of devices, such as a female connectorcombined with a male connector, the term “coupling” is used herein.Alternatively, the female connector can be combined with a male cap,which is also a “coupling” as used herein. In summary, as used herein acoupling is a female connector combined with either a male connector ora male cap. A female connector in turn is a portion of an infusiondevice, and the female connector contains a cavity or volume known asthe female luer. This cavity or volume known as the female luertypically has a tapered interior surface. The male connector and malecap each include a sealing extension called a male luer that fits withina female luer. The male luer typically has a tapered outer sealingsurface. A seal is formed when the tapered surface of the male luer onthe male connector or cap contacts the tapered surface of the femaleluer of the female connector. When these tapered surfaces are in contactwith one another the female connector and male connector or cap combineto form a coupling. This coupling can allow flow between infusiondevices (such as when a female connector and male connector combine) orprevent flow (such as when a female connector and male cap combine). Inboth cases it is highly desirable to have the seal between the femaleand male luers be constructed so as to form a fluid tight seal andprevent ingress of microbes, such as bacteria and fungi.

In certain implementations described herein, the male luer of the maleconnector or cap delivers an antimicrobial composition to the femaleluer of the female connector.

In one embodiment the male luer has a distal tip near its distal end,the distal tip surface containing an antimicrobial composition. Incertain implementations the male luer comprises a recess in theintermediate portion of its tapered outer sealing surface (between theproximal and distal ends of the tapered outer surface, but still on thetapered portion of the male luer), the recessed surface containing anantimicrobial composition. In certain implementations the male luercomprises a distal recessed portion (at the distal end of the male luer)and an intermediate recessed portion, with both recessed surfacescontaining an antimicrobial composition. In certain implementations themale luer comprises a flat end face at its distal end. In certainimplementations the male luer comprises an antimicrobial coating at theend face region. In certain implementations the male luer comprises anantimicrobial coating at a distal tip region.

Some examples of the technology herein provide a needleless connectorcomprising: a male connector having a male tapered surface, the maleconnector further including a distal tip having a distal end; the distaltip having a recess surface proximal to the distal end, wherein therecess surface is radially inward of a line of taper extending along,and distal of, the male tapered surface at a first taper angle relativeto a central longitudinal axis of the male connector; and awater-soluble antimicrobial composition positioned on the recesssurface.

In some examples, the male connector further comprises a tapered surfacedistal edge proximal to the distal tip of the male connector, thetapered surface distal edge being at a distalmost end of the maletapered surface. In some examples, the tapered surface distal edge isproximal to at least part of a recess defined by the recess surface ofthe male connector. In some examples, the distal tip has a proximal edgeabutting the tapered surface distal edge; the tapered surface distaledge has an outer diameter, the proximal edge of the distal tip has anouter diameter, and the outer diameter of the tapered surface distaledge is greater than the outer diameter of the proximal edge of thedistal tip. In some examples, the tapered surface distal edge defines aportion of the recess.

In still further examples, the needleless connector also has a fluidflow channel through the male connector. In some examples, theantimicrobial composition comprises chlorhexidine. In some examples, aplurality of blades extend radially outward from the recess surface. Insome examples, the plurality of blades have a plurality of bladesurfaces. In some examples, the blade surfaces contain at least aportion of the water-soluble antimicrobial composition. In someexamples, the blades are arranged substantially parallel to the centrallongitudinal axis.

In still further examples, the first taper angle is equal to a secondtaper angle of the recess surface relative to the central longitudinalaxis. In some examples, the distal tip defines a recess and the devicefurther comprises a proximal trap comprising a cavity at least partiallyopening into the recess. In some examples, at least a portion of thewater-soluble antimicrobial composition is contained within the proximaltrap.

Some examples of the technology herein provide a needleless connectorcomprising: a male connector having a male tapered surface configured toengage a female connector, the female connector having a female taperedsurface, such that the male tapered surface engages the female taperedsurface to form a fluid-tight seal, the male connector furtherincluding: a conical taper defined in part by the male tapered surface;a distal tip having a recess surface proximal to a distal end of themale connector, the recess surface residing inside the conical taper; atapered surface distal edge proximal to the distal tip, the taperedsurface distal edge having an outer diameter greater than the outerdiameter of the distal tip; a fluid flow channel through the maleconnector; and a water-soluble antimicrobial composition positioned onthe recess surface; wherein upon insertion of the male connector intothe female connector, an annular cavity is formed between the recesssurface and the female tapered surface of the female connector.

In some examples, the device is configured such that the annular cavitydefines an annular volume between the male connector and the femaleconnector, and wherein a portion of the antimicrobial composition isdissolvable into a fluid to form a chlorhexidine precipitate on aportion of the female tapered surface. In some examples, a plurality ofblades extend radially outward from the recess surface into the annularcavity to at least partially divide the annular cavity.

Some examples of the technology herein provide a needleless connectorfor delivering an antimicrobial composition into an infusion device, theneedleless connector comprising: a male connector having a male taperedsurface configured to insert into a female connector of an infusiondevice, the female connector having a female tapered surface, such thatthe male tapered surface engages the female tapered surface to form afluid-tight seal, the male connector having: a conical taper defined inpart by the male tapered surface; a distal tip having an outer diameterthat is less than 95 percent of an inner diameter of the female taperedsurface at a point radially outward of the distal tip; a recess surfaceproximal to the distal tip and inside the conical taper; a fluid flowchannel through the male connector; a water-soluble antimicrobialcomposition positioned on the recess surface; wherein, upon insertion ofthe male connector into the female connector, an annular cavity isformed between the recess surface and the female tapered surface of thefemale connector, the annular cavity having a proximal end and a distalend, a volume between the proximal end and the distal end, a widthmeasured radially, and a length measured axially; wherein the maletapered surface has a distal edge that at least partially defines theproximal end of the annular cavity, the distal end of the annular cavityis in fluid communication with a fluid lumen of the infusion device, andthe width of the annular cavity is less than 50 percent of the length ofthe annular cavity; and wherein a fluid inside the infusion device atleast partially fills the annular cavity, and at least a portion of theantimicrobial composition is dispersed within the fluid in the annularcavity.

In some examples, the distal tip defines a recess, the device furthercomprising a proximal trap comprising a cavity at least partiallyopening into the recess. In some examples, a plurality of blades extendradially outward from the recess surface into the annular cavity to atleast partially divide the annular cavity.

While embodiments are susceptible to various modifications andalternative forms, specifics thereof have been shown by way of exampleand drawings, and will be described in detail. It should be understood,however, that the scope herein is not limited to the particularembodiments described. On the contrary, the intention is to covermodifications, equivalents, and alternatives falling within the spiritand scope herein.

BRIEF DESCRIPTION OF THE DRAWINGS

The device may be more completely understood in connection with thefollowing drawings, in which:

FIG. 1A is a perspective view of a needleless connector according tosome examples.

FIG. 1B is a longitudinal cross-sectional view of the needlelessconnector of FIG. 1A.

FIG. 1C is an enlarged view of FIG. 1B inside circle C.

FIG. 2A is a schematic diagram of a patient undergoing peritonealdialysis, showing a peritoneal catheter extending into a peritonealcavity into which a dialysis solution is injected and then removed.

FIG. 2B is a perspective view of a proximal end of a peritoneal catheterwith a male cap installed on a female connector.

FIG. 2C is a perspective view of the proximal end of the peritonealcatheter of FIG. 2B showing the female connector after the male cap hasbeen removed.

FIG. 2D is a perspective view of the proximal end of the peritonealcatheter of FIG. 2C connected to a transfer set at a coupling formed bythe female connector and a male connector.

FIG. 3A is a cross-sectional view of a proximal end of a peritonealcatheter with a male cap installed on a female connector.

FIG. 3A′ is a closeup cross-sectional view of a portion of the proximalend of the peritoneal catheter and the female connector and the male capof FIG. 3A.

FIG. 3B is a cross-sectional view of the proximal end of the peritonealcatheter with the male cap installed on the female connector of FIG. 3Aafter microbes have infiltrated along a path.

FIG. 3B′ is a closeup cross-sectional view of a portion of the proximalend of the peritoneal catheter, specifically of the female connector,and the male cap of FIG. 3B.

FIG. 3C is a cross-sectional view of the proximal end of the peritonealcatheter, including the female connector, of FIG. 3B with the male caphaving been removed.

FIG. 3C′ is a closeup cross-sectional view of a portion of the proximalend of the peritoneal catheter, including the female connector, of FIG.3C.

FIG. 3D is a cross-sectional view of the proximal end of the peritonealcatheter, including the female connector, of FIG. 3C after cleaning.

FIG. 3D′ is a closeup cross-sectional view of a portion of the proximalend of the peritoneal catheter, including the female connector, of FIG.3D.

FIG. 3E is a cross-sectional view of the proximal end of the peritonealcatheter of FIG. 3D with a new male cap coupled to the female connector.

FIG. 3E′ is a closeup cross-sectional view of a portion of the proximalend of the peritoneal catheter of FIG. 3E, including a male luer of themale cap.

FIG. 3F is a cross-sectional view of the proximal end of the peritonealcatheter with the new male cap installed of FIG. 3E after a period oftime.

FIG. 3F′ is a closeup cross-sectional view of a portion of the proximalend of the peritoneal catheter with the new male cap installed of FIG.3F, including the male luer of the male cap.

FIG. 4A is a cross-sectional view of a proximal end of a peritonealcatheter with a male cap installed on a female connector, the male capincluding a male luer configured for delivery of an antimicrobial agent.

FIG. 4A′ is a closeup cross-sectional view of a portion of the proximalend of the peritoneal catheter with the male cap installed on the femaleconnector of FIG. 4A.

FIG. 4B is a cross-sectional view of the proximal end of the peritonealcatheter, including the female connector, with the male cap installed ofFIG. 4A after microbes have infiltrated along a path.

FIG. 4B′ is a closeup cross-sectional view of a portion of the proximalend of the peritoneal catheter with the male cap installed of FIG. 4B.

FIG. 4C is a cross-sectional view of the proximal end of the peritonealcatheter, including the female connector, of FIG. 4B with the male capremoved.

FIG. 4C′ is a closeup cross-sectional view of a portion of the proximalend of the peritoneal catheter of FIG. 4C.

FIG. 4D is a cross-sectional view of the proximal end of the peritonealcatheter of FIG. 4C, including the female connector, after cleaning.

FIG. 4D′ is a closeup cross-sectional view of a portion of the proximalend of the peritoneal catheter of FIG. 4D.

FIG. 4E is a cross-sectional view of the proximal end of the peritonealcatheter of FIG. 4D, including the female connector, with a new male capcoupled to the female connector, the male cap including a male luerconfigured for delivery of an antimicrobial agent.

FIG. 4E′ is a closeup cross-sectional view of a portion of the proximalend of the peritoneal catheter, including the female connector, of FIG.4E.

FIG. 4F is a cross-sectional view of the proximal end of the peritonealcatheter with the new male cap installed of FIG. 4E after a period oftime.

FIG. 4F′ is a closeup cross-sectional view of a portion of the proximalend of the peritoneal catheter with the new male cap installed of FIG.4F.

FIG. 5 is a closeup cross-sectional view of a coupling showing a femaleconnector on a proximal end of a peritoneal catheter with a maleconnector on a distal end of a transfer set.

FIG. 6A is a perspective view of a hemodialysis catheter, showing thehemodialysis catheter with two female connectors to which male caps havebeen coupled.

FIG. 6B is a perspective view of the hemodialysis catheter of FIG. 6A,showing the hemodialysis catheter with the two female connectors havingthe male caps removed.

FIG. 7A is a cross-sectional view of a female connector having aninfusion set connected, the infusion set comprising a male connectorhaving a male luer including a distal recess configured for delivery ofan antimicrobial agent.

FIG. 7A′ is a closeup cross-sectional view of a portion of the femaleconnector having the infusion set coupled to it, the infusion setcomprising the male connector having the male luer including the distalrecess configured for delivery of the antimicrobial agent of FIG. 7A.

FIG. 7B is a cross-sectional view of the female connector having theinfusion set connected, the infusion set comprising the male luerincluding the distal recess configured for delivery of the antimicrobialagent of FIG. 7A after a period of time.

FIG. 7B′ is a closeup cross-sectional view of a portion of the femaleconnector and the male luer including the distal recess configured fordelivery of the antimicrobial agent of FIG. 7B.

FIG. 8 is a cross-sectional view of an infusion set, the infusion setincluding a male connector having a tube connected, the male connectorincluding a male luer having a distal recess and an intermediate recessconfigured for delivery of an antimicrobial agent.

FIG. 8′ is a closeup cross-sectional view of the male luer of FIG. 8,showing the intermediate recess configured for delivery of anantimicrobial agent.

FIG. 9 is a cross-sectional view of a female connector having aninfusion device connected, the infusion device comprising a male luerincluding a distal recess and an intermediate recess, each recesscontaining an antimicrobial agent and configured for delivery of theantimicrobial agent.

FIG. 9′ is a closeup cross-sectional view of the female connector andthe male luer of FIG. 9 showing an enlargement of the distal recess ofthe male luer.

FIG. 9″ is a closeup cross-sectional view of the female connector andthe male luer of FIG. 9 showing an enlargement of a proximal end of thefemale connector and the intermediate recess of the male luer.

FIG. 10 is a cross-sectional view of a female connector having a malecap installed, the male cap comprising a male luer including a distalrecess containing an antimicrobial agent and configured for delivery ofthe antimicrobial agent.

FIG. 11 is a cross-sectional view of a female connector having aninfusion set connected, the infusion set comprising a male connectorwith a male luer including a distal recess containing an antimicrobialagent and an intermediate recess containing an antimicrobial agent.

FIG. 12 is a cross-sectional view of a female connector having aninfusion set connected, the infusion set having a male connector with amale luer including an intermediate recess containing an antimicrobialagent.

FIG. 13 is a cross-sectional view of a female connector having aninfusion set connected, the infusion set having a male connector with amale luer including an intermediate recess containing an antimicrobialagent.

FIG. 13′ is an enlarged cross-sectional view of the female connector andthe male luer of FIG. 13.

FIG. 14A is an isometric view of a needleless connector according tosome examples.

FIG. 14B is a side view of the needleless connector of FIG. 14A.

FIG. 14C is an end view of the needleless connector of FIG. 14A.

FIG. 15A is an isometric view of a male connector according to someexamples.

FIG. 15B is a side view of the male connector of FIG. 15A.

FIG. 15C is a cross-sectional view of the male connector of FIG. 15Aalong line C-C of FIG. 15B.

FIG. 15D is a cross-sectional view of the male connector of FIG. 15Aalong line D-D of FIG. 15B.

FIG. 15E is an end view of the male connector of FIG. 15A.

FIG. 15F is a cross-sectional view of the male connector of FIG. 15Aalong line F-F of FIG. 15E.

FIG. 16 is a cross-sectional view of a male connector according to someexamples.

FIG. 17A is an isometric view of a male connector according to someexamples.

FIG. 17B is a side view of the male connector of FIG. 17A.

FIG. 17C is a cross-sectional view of the male connector of FIG. 17Aalong line C-C of FIG. 17B.

FIG. 17D is an end view of the male connector of FIG. 17A.

FIG. 17E is a cross-sectional view of the male connector of FIG. 17Aalong line E-E of FIG. 17D.

FIG. 17F is a cross-sectional view of the male connector of FIG. 17Aalong line F-F of FIG. 17D.

FIG. 18A is an isometric view of a male connector according to someexamples.

FIG. 18B is a side view of the male connector of FIG. 18A.

FIG. 18C is a cross-sectional view of the male connector of FIG. 18Aalong line C-C of FIG. 18B.

FIG. 18D is an end view of the male connector of FIG. 18A.

FIG. 18E is a cross-sectional view of the male connector of FIG. 18Aalong line E-E of FIG. 18D.

FIG. 18F is a cross-sectional view of the male connector of FIG. 18Aalong line F-F of FIG. 18D.

FIG. 19A is an isometric view of a male connector according to someexamples.

FIG. 19B is a side view of the male connector of FIG. 19A.

FIG. 19C is a cross-sectional view of the male connector of FIG. 19Aalong line C-C of FIG. 19B.

FIG. 19D is an end view of the male connector of FIG. 19A.

FIG. 19E is a cross-sectional view of the male connector of FIG. 19Aalong line E-E of FIG. 19D.

FIG. 19F is a cross-sectional view of the male connector of FIG. 19Aalong line F-F of FIG. 19D.

FIG. 20A is an isometric view of a male connector according to someexamples.

FIG. 20B is a side view of the male connector of FIG. 20A.

FIG. 20C is a cross-sectional view of the male connector of FIG. 20Aalong line C-C of FIG. 20B.

FIG. 20D is a cross-sectional view of the male connector of FIG. 20Aalong line D-D of FIG. 20B.

FIG. 20E is an end view of the male connector of FIG. 20A.

FIG. 20F is a cross-sectional view of the male connector of FIG. 20Aalong line F-F of FIG. 20E.

FIG. 20G is a cross-sectional view of the male connector of FIG. 20Aalong line G-G of FIG. 20E.

FIG. 21A is an isometric view of a male connector according to someexamples.

FIG. 21B is a side view of the male connector of FIG. 21A.

FIG. 21C is a cross-sectional view of the male connector of FIG. 21Aalong line C-C of FIG. 21B.

FIG. 21D is an end view of the male connector of FIG. 21A.

FIG. 21E is a cross-sectional view of the male connector of FIG. 21Aalong line E-E of FIG. 21D.

FIG. 21F is a cross-sectional view of the male connector of FIG. 21Aalong line F-F of FIG. 21D.

FIG. 22A is an isometric view of a male connector according to someexamples.

FIG. 22B is a side view of the male connector of FIG. 22A.

FIG. 22C is a cross-sectional view of the male connector of FIG. 22Aalong line C-C of FIG. 22B.

FIG. 22D is an end view of the male connector of FIG. 22A.

FIG. 22E is a cross-sectional view of the male connector of FIG. 22Aalong line E-E of FIG. 22D.

FIG. 22F is a cross-sectional view of the male connector of FIG. 22Aalong line F-F of FIG. 22D.

FIG. 23A is an isometric view of a male connector according to someexamples.

FIG. 23B is a side view of the male connector of FIG. 23A.

FIG. 23C is a cross-sectional view of the male connector of FIG. 23Aalong line C-C of FIG. 23B.

FIG. 23D is an end view of the male connector of FIG. 23A.

FIG. 23E is a cross-sectional view of the male connector of FIG. 23Aalong line E-E of FIG. 23D.

FIG. 23F is a cross-sectional view of the male connector of FIG. 23Aalong line F-F of FIG. 23D.

FIG. 23G is a cross-sectional view of the male connector of FIG. 23Aalong line G-G of FIG. 23D.

FIG. 24A is an isometric view of a male connector according to someexamples.

FIG. 24B is a side view of the male connector of FIG. 24A.

FIG. 24C is a cross-sectional view of the male connector of FIG. 24Aalong line C-C of FIG. 24B.

FIG. 24D is a cross-sectional view of the male connector of FIG. 24Aalong line D-D of FIG. 24B.

FIG. 24E is a cross-sectional view of the male connector of FIG. 24Aalong line E-E of FIG. 24B.

FIG. 24F is an end view of the male connector of FIG. 24A.

FIG. 24G is a cross-sectional view of the male connector of FIG. 24Aalong line G-G of FIG. 24F.

FIG. 24H is a cross-sectional view of the male connector of FIG. 24Aalong line H-H of FIG. 24F.

FIG. 25A is an isometric view of a male connector according to someexamples.

FIG. 25B is a side view of the male connector of FIG. 25A.

FIG. 25C is a cross-sectional view of the male connector of FIG. 25Aalong line C-C of FIG. 25B.

FIG. 25D is a cross-sectional view of the male connector of FIG. 25Aalong line D-D of FIG. 25B.

FIG. 25E is an end view of the male connector of FIG. 25A.

FIG. 25F is a cross-sectional view of the male connector of FIG. 25Aalong line F-F of FIG. 25E.

FIG. 25G is a cross-sectional view of the male connector of FIG. 25Aalong line G-G of FIG. 25E.

FIG. 26A is an isometric view of a male connector according to someexamples.

FIG. 26B is a side view of the male connector of FIG. 26A.

FIG. 26C is a cross-sectional view of the male connector of FIG. 26Aalong line C-C of FIG. 26B.

FIG. 26D is a cross-sectional view of the male connector of FIG. 26Aalong line D-D of FIG. 26B.

FIG. 26E is an end view of the male connector of FIG. 26A.

FIG. 26F is a cross-sectional view of the male connector of FIG. 26Aalong line F-F of FIG. 26E.

FIG. 26G is a cross-sectional view of the male connector of FIG. 26Aalong line G-G of FIG. 26E.

FIG. 27A is an isometric view of a male connector according to someexamples.

FIG. 27B is a side view of the male connector of FIG. 27A.

FIG. 27C is a cross-sectional view of the male connector of FIG. 27Aalong line C-C of FIG. 27B.

FIG. 27D is a cross-sectional view of the male connector of FIG. 27Aalong line D-D of FIG. 27B.

FIG. 27E is an end view of the male connector of FIG. 27A.

FIG. 27F is a cross-sectional view of the male connector of FIG. 27Aalong line F-F of FIG. 27E.

FIG. 27G is a cross-sectional view of the male connector of FIG. 27Aalong line G-G of FIG. 27E.

FIG. 28A is an isometric view of a male connector according to someexamples.

FIG. 28B is a side view of the male connector of FIG. 28A.

FIG. 28C is a cross-sectional view of the male connector of FIG. 28Aalong line C-C of FIG. 28B.

FIG. 28D is an end view of the male connector of FIG. 28A.

FIG. 28E is a cross-sectional view of the male connector of FIG. 28Aalong line E-E of FIG. 28D.

FIG. 28F is a cross-sectional view of the male connector of FIG. 28Aalong line F-F of FIG. 28D.

FIG. 29A is an isometric view of a male connector according to someexamples.

FIG. 29B is a side view of the male connector of FIG. 29A.

FIG. 29C is a cross-sectional view of the male connector of FIG. 29Aalong line C-C of FIG. 29B.

FIG. 29D is a cross-sectional view of the male connector of FIG. 29Aalong line D-D of FIG. 29B.

FIG. 29E is an end view of the male connector of FIG. 29A.

FIG. 29F is a cross-sectional view of the male connector of FIG. 29Aalong line F-F of FIG. 29E.

FIG. 29G is a cross-sectional view of the male connector of FIG. 29Aalong line G-G of FIG. 29E.

FIG. 30A is an isometric view of a male connector according to someexamples.

FIG. 30B is a side view of the male connector of FIG. 30A.

FIG. 30C is a cross-sectional view of the male connector of FIG. 30Aalong line C-C of FIG. 30B.

FIG. 30D is a cross-sectional view of the male connector of FIG. 30Aalong line D-D of FIG. 30B.

FIG. 30E is an end view of the male connector of FIG. 30A.

FIG. 30F is a cross-sectional view of the male connector of FIG. 30Aalong line F-F of FIG. 30E.

FIG. 30G is an enlarged cross-sectional view of the the male connectorof FIG. 30A along line F-F of FIG. 30E.

FIG. 31A is an isometric view of a male connector according to someexamples.

FIG. 31B is a side view of the male connector of FIG. 31A.

FIG. 31C is a cross-sectional view of the male connector of FIG. 31Aalong line C-C of FIG. 31B.

FIG. 31D is a cross-sectional view of the male connector of FIG. 31Aalong line D-D of FIG. 31B.

FIG. 31E is an end view of the male connector of FIG. 31A.

FIG. 31F is a cross-sectional view of the male connector of FIG. 31Aalong line F-F of FIG. 31E.

FIG. 31G is a cross-sectional view of the male connector of FIG. 31Aalong line G-G of FIG. 31E.

FIG. 32A is an isometric view of a male connector according to someexamples.

FIG. 32B is a side view of the male connector of FIG. 32A.

FIG. 32C is a cross-sectional view of the male connector of FIG. 32Aalong line C-C of FIG. 32B.

FIG. 32D is a cross-sectional view of the male connector of FIG. 32Aalong line D-D of FIG. 32B.

FIG. 32E is an end view of the male connector of FIG. 32A.

FIG. 32F is a cross-sectional view of the male connector of FIG. 32Aalong line F-F of FIG. 32E.

FIG. 32G is a cross-sectional view of the male connector of FIG. 32Aalong line G-G of FIG. 32E.

FIG. 33A is an isometric view of a male luer cap according to someexamples.

FIG. 33B is a side view of the male luer cap of FIG. 33A.

FIG. 33C is a cross-sectional view of the male luer cap of FIG. 33Aalong line C-C of FIG. 33B.

FIG. 33D is an end view of the male luer cap of FIG. 33A.

FIG. 33E is a cross-sectional view of the male luer cap of FIG. 33Aalong line E-E of FIG. 33D.

FIG. 33F is a cross-sectional view of the male luer cap of FIG. 33Aalong line F-F of FIG. 33D.

FIG. 34A is an isometric view of a luer coupler according to someexamples.

FIG. 34B is a side view of the luer coupler of FIG. 34A.

FIG. 34C is an end view of the luer coupler of FIG. 34A.

FIG. 34D is a cross-sectional view of the luer coupler of FIG. 34A alongline D-D of FIG. 34C.

FIG. 34E is an enlarged view of FIG. 34D inside circle E.

FIG. 34F is an enlarged view of FIG. 34D inside circle F.

FIG. 35A is an isometric view of a luer coupler according to someexamples.

FIG. 35B is a side view of the luer coupler of FIG. 35A.

FIG. 35C is an end view of the luer coupler of FIG. 35A.

FIG. 35D is a cross-sectional view of the luer coupler of FIG. 35A alongline D-D of FIG. 35C.

FIG. 35E is an enlarged view of FIG. 35D inside circle E.

FIG. 35F is an enlarged view of FIG. 35D inside circle F.

FIG. 36 is a cross-sectional view of the luer coupler of FIG. 34Ainstalled between a female connector and a male connector according tosome examples.

FIG. 37 is a cross-sectional view of the luer coupler of FIG. 35Ainstalled between a female connector and a male connector according tosome examples.

FIG. 38 is a fluid flow model showing recirculating flow within amale-female luer connection under syringe load conditions.

FIG. 39 is a fluid flow model showing recirculating flow within amale-female luer connection under IV drip conditions.

It will be noted that in some cross-sectional figures the illustrationshave been simplified, such as removal of the background threads on thesealing cover to make the various aspects of the invention moreapparent. While embodiments are susceptible to various modifications andalternative forms, specifics thereof have been shown by way of exampleand drawings, and will be described in detail. It should be understood,however, that the scope herein is not limited to the particularembodiments described. On the contrary, the intention is to covermodifications, equivalents, and alternatives falling within the spiritand scope herein. For example, the term “infusion device” of FIG. 9 waschosen to point out that the examples are not limited to a specificinfusion device. The infusion device can be a needleless connector, atransfer set, an infusion set or other infusion devices having a maleconnector.

DETAILED DESCRIPTION

Numerous challenges are present for safely using medical devicesincorporating male and female connectors. For example, medical devicessuch as catheters used in hemodialysis, peritoneal dialysis, parenteralnutrition and chemotherapy are often worn for prolonged periods of timein the moist environment next to a patient's skin. This is an idealenvironment for bacterial growth. Peripherally inserted centralcatheters and midline catheters will typically have dozens ofconnections made between a male and female luer over the course of use,and each time the device is connected it provides an opportunity forinfection caused by ingress of organisms along the female luer. Andevery infusion device that has a female luer hub is susceptible to thefact that the interior female luer surface is not readily accessible tosanitizing wipes. Conventional sterilization methods are not able tokill microorganisms once they ingress to the female luer surface. Thus,these organisms are free to continue to ingress until reaching thebloodstream and ultimately creating a bloodstream infection. Inaddition, drug resistant organisms are becoming more common in hospitalsand outpatient healthcare settings, which makes treatment of bloodstreaminfections more difficult.

Multiple ingress pathways can lead to contamination of the female luersurface. One source of female luer contamination occurs when the femaleluer is open, with no male luer inserted. During the time the femaleluer is open, it is susceptible to airborne organisms landing on thesurface (such as from a person's breath or other source). Another sourceof female luer contamination is ingress along the threads and proximalend of the female hub, where organisms can then enter into the verysmall gap that exists between the proximal end of the male-female luersurfaces where the surfaces touch.

Those skilled in the art understand that organisms can ingress to theproximal end of the hub, but they are widely unaware that a gap existsbetween the male and female luers and that organisms can infiltrate thisgap where standard cleaning procedures are ineffective. Thus, the commonviewpoint is that cleaning the end of a female connector is sufficientto stop this route of organism ingress. The inventors have discoveredthat this is not sufficient; standard alcohol wiping/cleaning proceduresare not effective at killing the organisms that enter the inside of thefemale luer. Once inside the female luer, organisms can be pushed by theend face of the male luer into the lumen of the female luer device.

For example, use of needleless connectors on infusion devices is commonpractice. The needleless connectors are typically replaced every 4-7days, thus they are prone to contamination of the inside of the femaleluer, as described above, which can ultimately lead to bloodstreaminfection.

The technology disclosed herein provides a distal recess at the distaltip of the male luer member. The distal tip surface contains aconcentrated amount of an antimicrobial composition that remainsconfined within the cavity between the distal tip surface of the maleluer and tapered sealing surface of the female luer. Organisms insidethe female luer remain within the cavity, proximal to the lumen of themale luer. Various examples provided herein create an environment thatconfines the antimicrobial agent near the distal end of the male luer.

Referring now to the drawings, in another aspect described in relationto FIGS. 1A, 1B, and 1C, one implementation of the disclosed technologyprovides a needleless connector 111 having a male luer 141 at a distalend of the needleless connector 111. The male luer 141 includes a distaltip 155 and a tapered sealing member 142 with a tapered sealing surface143. The needleless connector 111 has a lumen 112 extending through theneedleless connector 111 through which fluid can flow. At the proximalend of the needleless connector 111, first threads 105 are provided formating the needleless connector 111 with another medical device, such asa luer lock syringe. At the distal end of the needleless connector 111,second threads 102 are provided for coupling the male luer 141 with amedical device having a female luer, such as the proximal end of acatheter for infusion of fluids, medications, or the like. The distaltip 155 also includes a distal tip surface 152 and a distal end face104. The tapered sealing member 142 has a tapered surface distal edge161 situated at the proximal end of the distal tip 155 and at the distalend of the tapered sealing surface 143.

As will be discussed further below, the male luer 141 forms a distalrecess 151 when inserted into a female connector. The distal tip surface152 can include an antimicrobial agent. The distal tip 155 is recessedinside a line of taper of the tapered sealing member 142. As usedherein, the line of taper is a representation of an imaginaryfrustoconical surface defining a conical taper extending beyond thetapered surface distal edge of the male luer. The line of taper issubstantially coincident with the female luer surface after the taperedsealing member is inserted into the female luer. The distal recess 151and a distal recess volume is defined by a space bounded by the femaleluer surface (which is similar to the line of taper), the taperedsurface distal edge face 162, and a plane coincident with a distal endof the distal tip 155. In the example of FIGS. 1A and 1B, the male luer141 further includes a proximal trap 171 at the proximal end of thedistal tip 155. The proximal trap 171 is defined as the space between aplane passing though tapered surface distal edge face 162 and theproximal trap walls 173. The proximal trap 171 is an annular cavity thatis bounded on multiple sides. The proximal trap 171 opens on the distalrecess 151. The proximal trap is adjacent to and proximal to the taperedsurface distal edge face 162. As will be discussed below in relation toFIGS. 38 and 39, the proximal trap 171 can store an antimicrobial agentwithin the annular cavity defined by the proximal trap 171.

A number of examples of male luer configurations are described below. Itshould be understood that each example below could be used in place ofthe male luer 141 of the needleless connector 111 shown in FIGS. 1A-C tocreate the needleless connector 111.

The needleless connector 111 may further comprise a compressible member113 and a spire 114. In some examples, the compressible member 113 ismade of a silicone material that forms a septum. In some examples, thespire can be formed from a hard material such as polycarbonate. There isan interference fit between the spire and silicone member.

FIG. 2A is a schematic diagram of a patient undergoing peritonealdialysis, showing a peritoneal catheter 10 extending into a peritonealcavity 12 (surrounded by peritoneum 13) of the patient into which adialysis solution from source bag 15 a flows into the patient. Thedialysis solution is then later drained into drain bag 15 b. Thecatheter 10 is in fluid communication with the bags 15 a and 15 b bymeans of a tubular transfer set 14 and an infusion set 16. Couplings 17and 18 are positioned on either end of the transfer set 14. Coupling 17joins the transfer set 14 to the catheter 10, while coupling 18 joinsthe transfer set 14 to the infusion set 16. Generally, the catheter 10and transfer set 14 are kept joined at coupling 17 for long periods oftime (weeks and months), while the transfer set 14 and infusion set 16are only joined at coupling 18 for the dialysis solution (dialysate)exchange process. This dialysis solution exchange process can take, forexample, 30 minutes up to four times a day for continuous ambulatoryperitoneal dialysis (CAPD), or overnight once a day for automatedperitoneal dialysis (APD).

During the CAPD exchange process the waste dialysis solution flows fromthe peritoneal cavity 12 through the catheter 10, on to the coupling 17and transfer set 14, then through coupling 18 and finally through thelower portion of the infusion set 16 into the drain bag 15 b. After theexchange process is complete, the infusion set 16 is separated atcoupling 18 from transfer set 14 and the female connector of transferset 14 is capped until the next dialysis solution exchange is initiated(not shown). Thus, in typical peritoneal dialysis the exchange processis initiated by removing a male cap from the female connector oftransfer set 14 and then joining to the infusion set 16 to form coupling18; and this process is reversed at the end of the exchange process byremoving the infusion set 16 at coupling 18 and installing a new malecap.

It will be appreciated that FIG. 2A has been simplified for clarity. Anautomated machine or different tubing arrangement may be used totransfer dialysis solution from the source bag 15 a to the peritonealcavity 12 or from the peritoneal cavity 12 to the drain bag 15 b. Themovement of the dialysis solution can be advanced by gravity, pumps, orother mechanisms.

Referring now to FIG. 2B, a perspective view of the proximal end of aperitoneal catheter 24 with a male cap 30 installed on a femaleconnector 40 is shown, while FIG. 2C is a perspective view of theproximal end of the peritoneal catheter 24 of FIG. 2B with the male capremoved, and FIG. 2D is a perspective view of the proximal end of theperitoneal catheter 24 of FIG. 2C connected to a transfer set 14. FIG.2B specifically shows a perspective view of the proximal end ofperitoneal catheter 24 having a tube 22 with a female connector 40 ontowhich a male cap 30 has been installed. Generally, the female connector40 includes a female luer inside (not shown), while the male cap 30includes a male luer (not shown). The proximal end of the peritonealcatheter 24 (that portion furthest from the patient) is shown along withfemale connector 40 and male cap 30. Also, the transfer set 14 of FIG.2D is shown in a foreshortened construction for ease in illustration.Normally the transfer set 14 is from approximately 6 to 18 inches longbut can be longer or shorter, and thus end 27 of tube 21 on transfer set14 often includes an extended length before joining to a secondconnector (not shown) that is typically capped between dialysistreatments, but which is then uncapped and joined to an infusion setduring dialysis.

FIG. 2C is a perspective view of the proximal end of the peritonealcatheter 24 of FIG. 2B with the male cap removed from the femaleconnector 40, including a female luer 42. The female luer 42 is a volumewithin the interior area of the female connector 40 that receives andseals with a male luer from a male cap or male connector. FIG. 2D is aperspective view of the proximal end of the peritoneal catheter 24 ofFIGS. 2A and 2B connected to a transfer set 14 by means of a maleconnector 50 comprising a male luer (the male luer is part of maleconnector 50 inside the end of the female connector 40 of peritonealcatheter 24, and not visible, but it will be understood that within thefemale connector 40 is a tapered male luer forming a seal with a femaleluer).

Now in reference to FIGS. 3A to 3F′, various stages of traditional capand connector installation and removal are shown, along with propertiesof microbial growth on the cap and connector. It should be noted that insome cross-sectional figures the illustrations have been simplified tomake the various aspects of the embodiments more apparent. FIG. 3A is across-sectional view of a proximal end of a peritoneal catheter 24 witha male cap 30 installed. FIG. 3A′ provides an enlarged cross-sectionalview of the proximal end of the peritoneal catheter 24 with male cap 30installed, corresponding for example to the construction of FIG. 2B,showing the female connector 40 with male cap 30. FIG. 3A showsdirectional arrows depicting the distal direction and the proximaldirection (an intermediate location would be between the distal andproximal directions). FIG. 3A further shows a male cap 30, with theproximal and distal ends of the male cap 30 labeled. Thus “proximal” and“distal” are relative terms, showing the position relative to thepatient and ends of a device.

As is shown in FIG. 3A, the male cap 30 includes a male luer 32 having atapered outer surface 33, while the female connector 40 has a femaleluer 42 with a tapered inner sealing surface 43 designed to seal withthe tapered outer surface 33 of the male luer 32. The end face 34 of themale luer 32 (which is at the distal end of the male cap 30) is exposedto the interior of a lumen 38 (open channel) through the femaleconnector 40. In FIG. 3A the male cap 30 is shown having threads 19,which engage with corresponding threads 23 of the female connector 40.The female connector 40 includes a female luer 42 which is a volumewithin the female connector 40. The female luer 42 in this embodimentincludes a tapered sealing surface 43. The female luer 42 of the femaleconnector 40 and the male luer 32 of the male cap 30 form a fluid-tightconnection at overlapping region 41. When the female connector 40 andmale cap 30 are threaded together they still can provide an infiltrationpath into an interstitial space or gap 35 (and subsequently into thelumen 38) as shown in FIGS. 3A and 3A′ where infiltration paths areshown, including past the threads 19, 23 to the interstitial space orgap 35 between the female connector 40 and male cap 30, morespecifically (but not exclusively) between the tapered inner sealingsurface 43 of the female luer 42 of the female connector 40 and thetapered outer surface 33 of male luer 32 of the male cap 30. Thisinterstitial space or gap 35 within the overlapping region 41 betweenthe tapered sealing surfaces 33, 43 of the male and female luers 32, 42is present during installation and removal of the male cap 30 but ourtesting shows the gap 35 also often exists after the male cap 30 hasbeen coupled to the female connector 40. When the male cap 30 isinserted into the female connector 40, the male and female luers 32, 42generally form a fluid tight seal somewhere within the overlappingregion 41 between them. However, the interstitial space or gap 35commonly exists along at least a portion of the overlapping region 41,thus allowing microbes 28 to infiltrate into the gap 35 from the femaleconnector end face 48 of the female connector 40.

FIGS. 3B and 3B′ show the cross-sectional views of FIGS. 3A and 3A′, butwith microbes 28 having infiltrated past the threads 19 and 23 (thethreads do not form a seal) and colonized portions of the interfacebetween the female connector 40 and male cap 30 at gap 35. Thisinfiltration and growth of microbes 28 is shown in schematicrepresentation (the sizes of the microbes in reality is much smaller,and distribution can be irregular).

FIG. 3C is a cross-sectional view of the peritoneal catheter 24 of FIGS.3A and 3B with the male cap 30 removed, exposing the female luer 42 intowhich the male luer 32 of a male cap or male connector can be inserted(not shown), and FIG. 3C′ is a closeup cross-sectional view of a portionof the proximal end of the peritoneal catheter of FIG. 3C, including thefemale connector end face 48 of the female connector 40. In FIGS. 3C and3C′ the microbes 28 are present on the female connector end face 48 ofthe female connector 40, and even after removal of the male cap 30 manyof the microbes 28 remain. Therefore, between dialysis treatments orother processes the female connector 40 often has high levels ofmicrobes present, including on the exposed female connector end face 48and threads 23 as well as on the tapered inner sealing surface 43 of thefemale luer 42 of the female connector 40. Thus, FIGS. 3C and 3C′ areessentially a representation of the female connector 40 after removal ofthe male cap.

FIG. 3D is a cross-sectional view of the peritoneal catheter of FIG. 3Cwith the male cap removed, and FIG. 3D′ is a closeup cross-sectionalview of a portion of the proximal end of the peritoneal catheter of FIG.3D. In FIGS. 3D and 3D′ the female connector 40 has been cleaned, suchas with an alcohol wipe, but microbes remain, in particular (in thisembodiment) on the tapered inner sealing surface 43 in the female luer42 of the female connector 40 because the cleaning wipes do not reachsufficiently inside the female luer 42 of the female connector 40 whenusing industry standard cleaning procedures.

FIG. 3E is a cross-sectional view of the peritoneal catheter 24 of FIG.3D with a new male cap 30′ installed, and FIG. 3E′ is a closeupcross-sectional view of the peritoneal catheter of FIG. 3E. The new malecap 30′ is typically a new, sterilized cap, and not the same male cap 30shown in FIGS. 3A and 3B because caps are not generally reused. In FIGS.3E and 3E′ it is shown how microbes 28 are pushed into the lumen 38 whena new male cap 30′ is installed. This occurs, in part, because a leadingedge 36 of the end face 34 of the male luer 32 on the new male cap 30′can push microbes down into the lumen 38 during installation of the malecap 30′. These microbes, which in FIG. 3D were on the tapered sealingsurface 43 of the female connector 40, are in FIG. 3E in a positiondistal to their position in FIG. 3D. The microbes are pushed in by theleading edge 36 of the male luer 32. Even if great care is taken to notscrape the walls of tapered inner sealing surface 43 of the female luer42, some microbes 28 can be pressed into the lumen 38. Once the new malecap 30′ is installed, the catheter or other infusion device is oftenleft alone for hours, days or even weeks, during which time the microbes28 can multiply and spread further into the lumen 38, as shown in FIGS.3F and 3F′. FIGS. 3F and 3F′ show a cross-sectional view of theperitoneal catheter 24 with the new male cap 30′ installed of 3E and3E′, after a period of time during which microbes 28 have increased inpopulation and begun colonizing down the walls of the lumen 38, wherethey can eventually reach into the patient either by continued growthand/or by becoming released from the walls of lumen 38 during fluid flowand thus flushed into a patient, thereby promoting infection in, andeven death of, the patient.

FIG. 4A is a cross-sectional view of a peritoneal catheter containing afemale connector 40, with a male cap 30 installed on the femaleconnector 40; the male cap 30 containing an antimicrobial agent 29 on amale luer 32 of the male cap 30. More specifically, the antimicrobialagent 29 is on the tapered sealing surface 33 of the male luer 32. Theantimicrobial agent 29 extends down into a gap 35 (similar to the gap 35of FIGS. 3A to 3F, but now with the antimicrobial agent 29 present).FIG. 4A′ is a closeup cross-sectional view of a portion of the proximalend of the peritoneal catheter of FIG. 4A.

FIG. 4B is a subsequent (in time) cross-sectional view of the peritonealcatheter of FIG. 4A with the male cap 30 installed, and FIG. 4B′ is acloseup cross-sectional view of a portion of the proximal end of theperitoneal catheter of FIG. 4B. In FIGS. 4B and 4B′ the microbes 28 thatmake contact with the antimicrobial agent 29 are represented as beingdead microbes 28 x. Thus, the number of surviving microbes 28 present issignificantly smaller due to the antimicrobial agent 29. The microbes 28and dead microbes 28 x are shown as a schematic representation, ratherthan showing actual living or dead microbes drawn to scale. The deadmicrobes 28 x thus represent either dead microbes themselves, as well asplaces where microbes have infiltrated and died (and possibly thenfallen away or otherwise moved). Thus, FIGS. 4B and 4B′ show how thepresence of antimicrobial on the infiltration path can reduce microbesat the interface between the tapered sealing surfaces 33, 43 of the maleand female luers 32, 42, thereby preventing movement and growth ofmicrobes 28 down the infiltration path.

FIGS. 4C and 4C′ show the end of the female connector 40 of FIGS. 4A and4A′ after removal of the male cap, showing dead microbes 28 x on thetapered inner sealing surface 43 of the female luer 42 of the femaleconnector 40. Even though there may be some microbes 28 on the femaleconnector end face 48 of the female connector 40, the microbes on thetapered portions of the female luer 42 are shown dead (meaning they canbe microbes that have been killed by the antimicrobial and/or can beplaces where microbes did not grow).

FIGS. 4D and 4D′ show the female connector of FIGS. 4C and 4C′ aftercleaning the end of the female connector 40. In contrast to early FIGS.3D and 3D′, both the end and interior of the female connector 40 arefree (or substantially free) of living microbes. Thereafter, uponinsertion of a new male cap, with the new male cap containing anantimicrobial agent on a male luer of the male cap, as shown in FIGS. 4Eand 4E′, dead microbes 28 x are pushed into the lumen 38, but these deadmicrobes 28 x fail to grow, as shown in FIGS. 4F and 4F′ (whichrepresent a subsequent period in time, such as 48 to 72 hours, after thepoint shown in FIGS. 4E and 4E′).

FIG. 5 is a cross-sectional view of a peritoneal catheter 24 with adistal end of a transfer set 14 connected. FIG. 5 corresponds generallyto the dialysis stage of FIG. 2D, wherein the transfer set allows forfluid to flow between the dialysis solution and into and out of thepatient's peritoneal cavity. In FIG. 5 a female connector 40 of theperitoneal catheter 24 is joined to a male connector 50 of the transferset 14. The transfer set 14 further comprising a tube 57 (such as a tubefor transferring dialysis fluid) that is attached to male connector 50.The male connector 50 comprises a male luer 52 with a tapered outersurface 53, and threads 23. Tube 57 includes an inner lumen 58. The maleluer 52 of male connector 50 includes the tapered outer surface 53 thathas a truncated conical surface, along with an end face 54. This design,similar to those shown in FIG. 3A to 3F, is also subject to infiltrationand ingrowth of microbes, resulting in infections in a patient. The sameprincipals of antimicrobial use in FIGS. 4A to 4F, in which the maleluer 52 includes an antimicrobial, can be used to control microbialinfiltration and growth and subsequent infections, specificallyinclusion of a coating of antimicrobial agent on the outside of the maleluer 52, such as at the distal end or intermediate portion of the maleluer 52, or both (for example).

FIGS. 6A and 6B show an alternative infusion device, in this case a ahemodialysis catheter 60 with female connectors 62, 64 and two tubes 61,63 containing internal lumens (not shown) that run down the main section65 of the catheter 60. FIG. 6A is a perspective view of the hemodialysiscatheter, showing the hemodialysis catheter with two female connectors62, 64 having caps 66, 68 installed. The hemodialysis catheter 60 isalso shown with clamps 67, 69, the clamps shown in a closed orientation.The clamps 67, 69 are open during dialysis, but then closed betweendialysis sessions and when the caps 66, 68 are being removed andinserted. FIG. 6B is a perspective view of the hemodialysis catheter 60,showing the hemodialysis catheter with two female connectors 62, 64having caps removed. The female connectors 62, 64 are shown, as well asfemale luers 71, 73.

FIG. 7A is a cross-sectional view of an infusion set 16 connected to afemale connector 40. The infusion set 16 has a male connector 50 and atube 57. The male connector 50 has a male luer 52, the male luer 52includes a distal recess 80 configured for delivery of an antimicrobialagent 29 (shown in FIG. 7A′). The distal recess 80 forms a cavity 81once the male luer 52 is installed into a female luer 42 of the femaleconnector 40. Female connector 40 includes a lumen 38 in fluidconnection to lumen 58 in tube 57. The male luer 52 includes a taperedouter surface 53 that has a partial conical surface, along with an endface 54. Near the end face 54 is a distal recess 80 containing theantimicrobial agent 29 (shown in FIG. 7A′), such as chlorhexidine. Theantimicrobial agent 29 is typically a dry-antimicrobial, and provides anantimicrobial effect to the interior surfaces of the female connector40, especially at the region in the vicinity of the distal recess 80 ofthe male luer 52, and the area around where it meets the tapered innersealing surface 43 of the female luer 42 of the female connector 40. Asthe male luer 52 is inserted into the female connector 40, the microbes28 are pushed by tapered surface distal edge 55 of the male luer 52rather than end face 54; thus, the microbes 28 are concentrated withinthe cavity 81 formed between the distal recess 80 and the female luer42. The antimicrobial agent 29 may become wetted by fluid from lumens 58and 38 when male connector 50 are connected with female connector 40.However, the fluid is (in certain embodiments) substantially retainedwithin the cavity 81 even when fluid flows through the male connector 50(which includes the male luer 52) because the cavity 81 only has a smallopening (at the distal end of the distal recess 80, near the end face54). This results in a high concentration of antimicrobial agent in thefluid in the cavity 81 without substantially depleting the antimicrobialagent 29 from the male luer 52. Thus, the antimicrobial agent within thefluid in the cavity 81 is at a lethal concentration for a sufficienttime to kill the microbes 28 that were present on the female connectorprior to connecting the male connector to the female connector.

FIG. 7B is a cross-sectional view of the male connector and femaleconnector of 7A after a period of time. FIG. 7B′ is a closeupcross-sectional view of a portion of the male and female luers of FIG.7B. The microbes 28 x are dead after being in contact with theantimicrobial agent 29 within the cavity 81 for the period of time. Thedead microbes 28 x will not multiply and will not cause an infection toa patient.

FIG. 8 is a cross-sectional view of an infusion set 16; the infusion set16 including a male connector 50 and a tube 57, the male connector 50comprising a male luer 52 including a distal recess 80, an end face 54and an intermediate recess 82 configured for delivery of anantimicrobial agent. FIG. 8′ is a close-up cross-sectional view of anintermediate recess 82 of the male luer 52. The male luer 52 includes atapered outer surface 53 that has a truncated conical surface. Thedistal recess 80 contains an antimicrobial agent 29, and theintermediate recess 82 is proximal from the end face 54. Theantimicrobial agent 29 is typically a dry-antimicrobial. FIG. 8′ showsthe intermediate recess 82, along with edges 83 and 84 of the recess. Insome implementations the edges 83, 84 are smooth transitions with thetapered outer surface 53 of the male luer 52, while in otherimplementations the edges 83, 84 are more pronounced and defined, asshown in FIG. 8′. In one embodiment, edge 83 is removed and intermediaterecess 82 continues distally until reaching the unmodified taperedsealing surface 53 of the male luer 52 (shown in FIG. 9″); this is forease of injection molding. The infusion set 16 may be used to connect toa female connector (not shown); thus providing similar infectionprevention benefits described elsewhere herein.

FIG. 9 is a cross-sectional view of a portion of an infusion device 20connected to a female connector 40. The infusion device 20 including atube 57 joined to a male connector 50; the male connector 50 comprisinga male luer 52 having a tapered outer surface 53. The male luer 52 ofthe male connector 50 includes an intermediate recess 82 in the taperedouter surface 53 containing an antimicrobial agent 29 and configured fordelivery of the antimicrobial agent (intermediate recess referring tothe recessed portion situated between the distal end and the proximalend of the tapered outer surface 53). The male luer 52 also includes adistal recess 80 at its distal end containing antimicrobial agent 29.The distal recess 80 forms a cavity 81 once the male luer 52 isinstalled into a female luer 42 of the female connector 40. FIG. 9′ is acloseup cross-sectional view of the male luer 52 and female connector 40of FIG. 9, showing an enlargement of the distal recess 80 which forms acavity 81, the male luer 52, and female connector 40. Female connector40 includes a lumen 38 in fluid connection to lumen 58 on tube 57 of theinfusion set 16. The male luer 52 includes a tapered outer surface 53that has a partial conical surface (a surface that correspondssubstantially to the bottom of a cone), along with an end face 54. Nearthe end face 54 is the distal recess 80 containing antimicrobial agent29.

FIG. 9″ is a closeup cross-sectional view of the male luer 52 and theproximal end of the female connector 40 and the intermediate recess 82of the male luer 52. In FIG. 9″ the proximal edge 84 of intermediaterecess 82 is shown. This proximal edge 84 can be, for example, a definedindent or a simple taper. The intermediate recess 82 extends bothproximally and distally from a proximal-most end of the tapered innersealing surface 43 of the female connector 40; thus providing a regionfor retaining a high concentration of the antimicrobial agent, which isretained by surface tension while the antimicrobial agent is in adissolved state or partially dissolved state in a fluid. Theantimicrobial reverts back to a dry-antimicrobial after the fluid haddried, with at least a portion of the antimicrobial agent being retainedin the intermediate recess.

The antimicrobial agent is typically a dry-antimicrobial, and providesan antimicrobial effect to the interior of the female connector 40,especially at the region in the vicinity of the distal recess 80 of themale luer 52, the intermediate recess 82, and the overlapping region 41(overlap of the tapered inner sealing surface 43 of the female luer 42,and the tapered outer surface 53). When the male luer 52 of the maleconnector 50 is inserted into the female luer 42 of the female connector40, the microbes 28 are pushed by the tapered surface distal edge 55 ofthe male luer 52 rather than the end face 54; thus the microbes 28 areconcentrated within the cavity 81. The antimicrobial agent 29 may becomewetted by fluid in lumens 38 and 58 as the fluid flows into the recesswhile connecting male connector 50 to female connector 40. However,after connection, the fluid is substantially retained within the cavity81 even when fluid flows through the male connector 50 because thecavity 81 only has one opening (at the distal end of the distal tip).This results in a high concentration of antimicrobial agent in the fluidin the cavity 81 without substantially depleting the antimicrobial agent29 from the male connector 50. Thus, the antimicrobial agent within thefluid is at a lethal concentration for a sufficient time to kill themicrobes 28.

The proximal edge 84 of intermediate recess 82 is located proximal tothe proximal end of tapered inner sealing surface 43, but can optionallybe located distal to the proximal end of the tapered inner sealingsurface 43 of the female luer 42. Some benefits of intermediate recess82 as shown in FIG. 9 are it provides a reservoir of antimicrobial agent29 at the proximal end of the female connector 40 (killing the microbeswhere they enter) and, at the same time, it reduces the stress on theproximal end of the female connector 40, thus preventing stress crackingof the female connector.

In an example embodiment, the antimicrobial agent is located along theentire tapered outer surface 53 of the male connector 50, in therecesses 80, 82 and along male connector threaded surface 39 of a maleconnector 50 (the male connector threaded surface 39 including theproximal most surface that is adjacent to the proximal end of thetapered outer surface 53). The flow of a fluid in the lumen 38 isstopped by activating a first clamp, valve or other flow-stopping means(not shown) located distal to the female connector 40, and flow of afluid in the lumen 58 is stopped by activating a second clamp, valve orother flow-stopping means (not shown) located proximal to the maleconnector 50. Prior to connecting the male connector 50 to the femaleconnector 40, the first and second clamps are activated to prevent fluidflow within the lumens 38, 58. After activating the clamps, and as themale luer 52 is inserted into the female luer 42, the fluid inside thelumens 38, 58 is displaced creating an outward flow of the fluid betweenthe tapered surfaces 43, 53 and into a channel 59 located outside thefemale connector 40 and inside the male connector threaded surface 39.As the fluid flow contacts the antimicrobial agent, a portion of theantimicrobial agent is dissolved and incorporated into the fluid; thuscreating an antimicrobial fluid. The antimicrobial fluid then flows intothe channel 59 where it contacts the female connector end face 48 andthe female connector threaded surface 49, which subsequently killsmicrobes (not shown in FIG. 9, but similar to the microbes 28 shown inFIGS. 3B′, 3C′ and 4C′) on the female connector end face 48 and threadedsurface 49. This is beneficial for killing microbes that may remainafter cleaning the female connector end face 48 and threaded surface 49with a wipe as described in the narrative of FIGS. 3D′ and 4D′. Overtime, the antimicrobial fluid will dry, leaving a dry antimicrobialagent coating on the female connector 40 at the female connector endface 48 and threaded surface 49; thus creating an antimicrobial femaleconnector in-situ. The antimicrobial is, for example, chlorhexidineacetate, which is dry and has a persistent antimicrobial effectiveness.In comparison, an alcohol antimicrobial, as found in many prior artdevices, typically has no persistent antimicrobial effectiveness afterthe alcohol antimicrobial dries. As saline contacts chlorhexidineacetate, some of the chlorhexidine acetate is converted to chlorhexidinedihydrochloride, which adheres to the surfaces of the female connector;thus providing antimicrobial properties to the female connector in-situ.

In some embodiments it is desirable to apply a slowly dissolving(“time-release”) coating on top of the antimicrobial agent to delay orslow the time for the antimicrobial agent to dissolve. A time-releasecoating, especially when applied to distal recess 80, is advantageousfor ensuring a precise dose of antimicrobial agent is available withinthe cavity 81 once the connectors 40, 50 have been coupled together. Inanother embodiment it is desirable to use an antimicrobial mixture toslow the antimicrobial mixture's dissolution rate; the antimicrobialmixture comprising the antimicrobial agent and a material that dissolvesslower, such as a hydrophilic water-soluble polymer. In yet anotherembodiment it is desirable to use chlorhexidine base with achlorhexidine salt (such as chlorhexidine acetate) to achieve theintended dissolution rate; thus providing a means and method to controlthe amount of antimicrobial agent being removed from the recesses 80, 82and tapered outer surface 53, transferring a portion of theantimicrobial agent to the female connector end face 48 and femaleconnector threaded surface 49, where upon drying, a portion of theantimicrobial agent remains on the female connector end face 48 andfemale connector threaded surface 49. The benefit is this provides apersistent antimicrobial agent along the infiltration path (as shown inFIG. 3A) to prevent microbe ingress and subsequent infections.

FIG. 10 is a cross-sectional view of a female connector 40 having a malecap 30 installed; the male cap 30 comprising a male luer 32 including adistal recess 80 containing an antimicrobial agent; the male cap 30configured for delivery of the antimicrobial agent. The distal recess 80forms a cavity once the male luer 32 is installed into a female luer 42of the female connector 40. Female connector 40 includes a lumen 38. Themale luer 32 includes a tapered outer surface 33 that has a truncatedconical surface, an end face 34, and near the end face 34 is a distalrecess 80 containing the antimicrobial agent, such as chlorhexidine. Inone embodiment, the distal recess 80 is a truncated conical surface thatis recessed 0.001″ to 0.015″ below a projection of the tapered outersurface 33. The antimicrobial agent is typically a dry-antimicrobialthat is water soluble, and provides an antimicrobial effect to anoverlapping region 41 (overlap of a tapered outer surface 33 of a maleluer 32 of the male cap 30 and the tapered inner sealing surface 43 of afemale luer 42 of the female connector 40), especially at the region inthe vicinity of the distal recess 80 of the male luer 32.

As the male luer 32 is inserted into the female luer 42 of the femaleconnector 40, microbes are pushed by the tapered surface distal edge 55of the male luer 32 rather than end face 34; thus the microbes areconcentrated within the cavity. The antimicrobial agent in the cavitymay become wetted by fluid in lumen 38 being displaced as male luer 32is inserted into female luer 42. The fluid is substantially lockedwithin the cavity in some embodiments because the cavity only has oneopening (at the distal end of the recess) after the male luer 32 isfully inserted into the female connector 40. This results in a highconcentration of antimicrobial agent in the fluid in the cavity withoutsubstantially depleting the antimicrobial agent. Thus, the antimicrobialagent within the fluid is at a lethal concentration for a sufficienttime to kill the microbes and prevent ingrowth of microbes.

FIG. 11 is a cross-sectional view of a female connector 40 having aninfusion set 16 connected, the male connector 50 having a male luer 52including an intermediate recess 82 containing an antimicrobial agent 29and configured for delivery of the antimicrobial agent. Near the endface 54 is the cavity containing an antimicrobial agent 29, and theintermediate recess 82 is set back proximal to the end face 54 and alsocontains an antimicrobial agent.

FIG. 12 is a cross-sectional view of a female connector 40 having aninfusion set 16 connected. The tapered sealing surface 53 of the maleluer 52 of the male connector 50 is bisected with an intermediate recess82 containing an antimicrobial composition. The proximal and distal endof the bisected tapered sealing surface 53 reside on the same conicaltapered geometry to form a fluid tight seal with the tapered sealingsurface 43 of the female connector 40. The intermediate recess 82 of themale luer 52 contains an antimicrobial agent; the male luer 52configured for delivery of the antimicrobial agent. The female connector40 includes a lumen 38 in fluid connection with tube 57. The male luer52 includes an end face 54. The intermediate recess 82 is set backproximal from the end face 54.

FIG. 13 is a cross-sectional view of an infusion set 16 connected to afemale connector 40. The male luer 52 of a male connector 50 of theinfusion set 16 including an intermediate recess 82 that bisects thetapered outer surface 53. The intermediate recess 82 contains anantimicrobial agent 29 and configured for delivery of the antimicrobialagent 29. The tapered outer surface 53 also contains the antimicrobialagent 29. FIG. 13′ is a closeup cross-sectional view of the femaleconnector 40 connected to the infusion set of FIG. 13, showing anenlargement of the female connector 40 and an intermediate recess 82 ofthe male luer 52. Female connector 40 includes a lumen 38 in fluidconnection with a lumen 58 of tube 57. The male luer 52 includes atapered outer surface 53 that has a truncated conical surface, alongwith an end face 54. The intermediate recess 82 is set back proximalfrom the end face 54 and includes an antimicrobial agent 29, as shown inFIG. 13′.

It will be appreciated that this is just an illustrated example, andthat alternative peritoneal dialysis configurations are possible. Also,it will be appreciated that peritoneal dialysis is just one example of ause for the infusion connectors and systems disclosed herein, and thatalternative uses and systems include hemodialysis catheters,peripherally inserted central catheters, midline catheters, drainagecatheters, needleless connectors, intravenous (IV) administration sets,peritoneal dialysis lines, transfer set, syringes, valves and filters.

Examples of Antimicrobial Agents

The inventors have identified that it is desirable to use only a smallamount of antimicrobial for safety because it reduces patient risk inthe event antimicrobial escapes into the body. The amount considered a“low dose” is different from patient to patient. For example, achlorhexidine acetate dose of 500 μg (micrograms) or higher may beconsidered safe for direct injection into a 60 kilogram person'sbloodstream, but a dose significantly below this level is desirable foruse in neonates.

The various embodiments herein have benefit over prior art from a safetystandpoint because by delivering the antimicrobial agent between theluer surfaces, only a small amount of antimicrobial agent is required tokill microbes. In the various examples provided here, an annular cavityis formed between the male luer surface and the female luer surface whenthe male luer is installed into a female luer. The concentration ofantimicrobial agent is high but the total dose is low because the gapbetween the luer surfaces is very small and there is little to no fluidflow away from this region, causing loss of the antimicrobial to be verylow.

In some embodiments the antimicrobial agent can be chlorhexidineacetate. A concentration of greater than 200 μg/mL (micrograms permilliliter) of chlorhexidine acetate can quickly kill most microbes,including Gram positive bacteria, Gram negative bacteria, and fungi.

In various embodiments the male luer has a recess surface (also referredto as distal tip surface) containing approximately 25 to 250 μg ofchlorhexidine acetate. For example, in an embodiment, the radial depthof the recess is approximately 0.005 inches (0.127 millimeters) and theaxial length is approximately 0.020 inches to 0.040 inches long (0.508mm to 1.016 mm). The annular cavity formed between the male luer surfaceand the female luer surface can have a volume on the order of 1(microliter) or 0.001 mL. If 10 μg of chlorhexidine acetate is in a 1 μLvolume, the antimicrobial concentration is 10,000 μg/mL, which is 50times higher than the minimum desired level of 200 μg/mL to killmicrobes. This demonstrates how the invention can create very highmicrobe kill efficacy while at the same time providing excellent patientsafety; 50 μg of chlorhexidine acetate distributed over the entiresurface of the male luer is 10 times lower than the maximum total doseof 500 μg that is desired for patient safety.

In some embodiments the volume of the annular cavity is between about 1and 10 microliters. In some embodiments, the volume of the annularcavity can fall within a range of 1 microliters to 25 microliters, or 5microliters to 20 microliters, or 10 microliters to 15 microliters, orcan be about 10 microliters. In some embodiments, the volume of theannular cavity can be greater than or equal to 1 microliters, 2microliters, 3 microliters, 4 microliters, 5 microliters, 6 microliters,6 microliters, 7 microliters, 8 microliters, 9 microliters, or 10microliters. In some embodiments, the volume of the annular cavity canbe less than or equal to 25 microliters, 24 microliters, 22 microliters,20 microliters, 19 microliters, 18 microliters, 16 microliters, 14microliters, 13 microliters, 12 microliters, or 10 microliters.

Additionally, a number of different examples of antimicrobial agents canbe used with the various embodiments described herein. The antimicrobialcompositions should kill and/or provide stasis of Gram-positive andGram-negative bacteria and fungi. The agents may also have efficacy atkilling organisms within an established biofilm and/or degrading theextracellular matrix of the film. However, this is not necessary for theinvention to be beneficial because the invention is designed to killorganisms before they have an opportunity to form a biofilm. Theantimicrobial composition can be chlorhexidine acetate, also known aschlorhexidine diacetate.

Other compounds containing chlorhexidine may be used, such aschlorhexidine free base, chlorhexidine gluconate and chlorhexidine withdyes. Chlorhexidine acetate has an advantage over chlorhexidinegluconate because the risks associated with para chloroaniline may beminimized.

Other suitable antimicrobial compositions may also be used. In general,the antimicrobials are soluble in water, they have a history of clinicaluse with a demonstrated safety profile, they are antibiotic-free, theycan be applied onto a medical device, and they can be subsequentlydissolved into a composition having an effective concentration toinhibit growth of bacterial and fungal organisms. Suitable materialsinclude chlorhexidine, chlorhexidine salts (such as chlorhexidineacetate or chlorhexidine gluconate), tetrasodiumethylenediaminetetraacetic acid (tetrasodium EDTA), sodium citrate(yielding a concentration of 30% or higher), iodine, taurolidine,disodium EDTA, silver compounds (including silver nanoparticles andions), silver sulfadiazine, and, triclosan. In some examples, a portionof the antimicrobial composition is dissolvable to form a chlorhexidineprecipitate.

While one drug or antimicrobial composition may provide relief from awide range of challenging organisms that could potentially lead tocatheter-related bloodstream infection, two or more agents may be usedto increase efficacy against a broad range of infectious organisms(bacteria and fungi).

In particular, catheter-related infections arise from three broadclasses of organisms: fungi, Gram-negative bacteria, and Gram-positivebacteria. If an antimicrobial composition can be identified that wouldabate one or two of these types of organisms, while this would certainlybe beneficial, it would leave the patient vulnerable to the remainingtype(s). By pairing agents with different modes of action, infections byan increased spectrum of organisms can be prevented. This synergy wouldlikely lead to further decreases in catheter-related morbidity andmortality, lessening the impact of the implanted catheter on thepatient's quality of life. Example combinations of antimicrobialcompositions are chlorhexidine acetate and EDTA, silver sulfadiazine andchlorhexidine acetate, and silver sulfadiazine and methylene blue.

In principle, antibiotics (rifampin, minocycline, etc.) can beincorporated into or onto the male luer or similar device and be aseffective as non-antibiotic antimicrobials. However, continuous exposureto one antibiotic can lead to antibiotic resistant bacteria strains, forexample, methicillin resistant S. aureus (MRSA). Therefore, an exampleembodiment uses an antimicrobial composition selected from the subset ofthose which are not antibiotics. If, for some reason, an antibiotic isused, the risk of developing antibiotic resistant strains of bacteriamay be mitigated by preparing a second, complimentary, device containinga different antibiotic. By using the two devices in an alternatingfashion with successive uses, infectious organisms that are resistant toone antibiotic may be killed by the other.

In certain implementations the antimicrobial agent compriseschlorhexidine, chlorhexidine base, chlorhexidine acetate and/orchlorhexidine gluconate. In certain implementations the antimicrobialagent is a dry coating.

In certain implementations the antimicrobial agent is water soluble atgreater than 1 mg/mL. In certain implementations the agent is watersoluble at greater than 10 mg/mL. In certain implementations a firstantimicrobial agent is water soluble at less than 1 mg/mL and a secondantimicrobial is soluble at greater than 10 mg/mL. In certainimplementations the antimicrobial agent is impregnated into the luersurface. In certain implementations the antimicrobial agent is abroad-spectrum compound capable of killing Gram positive bacteria, Gramnegative bacteria, and fungi. In certain implementations theantimicrobial agent is a non-antibiotic antimicrobial. In certainimplementations the antimicrobial agent converts into chlorhexidinedihydrochloride in presence of saline.

In certain implementations the antimicrobial agent comprises silver orsilver sulfadiazine. In certain implementations the antimicrobial agentcontains more than one compound. In certain implementations theantimicrobial agent comprises chlorhexidine and silver sulfadiazine. Incertain implementations the antimicrobial agent comprises theantibiotics minocycline and rifampin.

In certain implementations the antimicrobial agent is applied in asolvent-based coating process. In certain implementations theantimicrobial agent is applied in a spray process. In certainimplementations the antimicrobial agent is applied in a dip process. Incertain implementations the antimicrobial agent is dispersed in bulkmaterial of an injection molding process. In certain implementations theantimicrobial agent is part of an antimicrobial solution that contains asolvent that swells the device material, which allows the antimicrobialagent to impregnate the device material, where it remains after solventevaporates.

Needleless Connector (FIGS. 14A-C)

In another aspect described in relation to FIGS. 14A-14C, oneimplementation of the disclosed technology provides a needlelessconnector 1411 having a male connector 1401 at a distal end of theneedleless connector 1411, the male connector 1401 includes a male luer1441 and threads 1402. The male luer 1441 includes a tapered sealingmember 1442 with a tapered sealing surface 1443. The needlelessconnector 1411 has a lumen 1412 extending through the needlelessconnector 1411 through which fluid can flow. At the needleless connectorproximal end 1407 of the needleless connector 1411, threads 1405 areprovided for connecting the needleless connector 1411 to another medicaldevice, such as a syringe. At the distal end of the needleless connector1411, threads 1402 are provided for coupling the male luer 1441 with amedical device having a female luer, such as the proximal end of acatheter for hemodialysis, peritoneal dialysis, parenteral nutrition, orchemotherapy. The distal tip 1455 also includes a distal tip surface1452 and an end face 1404. The tapered sealing member 1442 has a taperedsurface distal edge 1461 adjacent and proximal to the distal tip 1455.The tapered surface distal edge 1461 is situated at the distalmost endof the tapered sealing surface 1443.

As will be discussed further below, the male luer 1441 includes a distalrecess 1451, and the distal tip 1455 has a distal tip surface 1452. Thedistal tip surface 1452 can include an antimicrobial agent as describedabove. When the male luer 1441 is installed into a female luer (notshown), a cavity is created between the tapered sealing surface of thefemale luer and the distal tip surface 1452 of the male luer 1441. Thedistal tip 1455 is recessed inside the line of taper of the taperedsealing surface 1443. As used herein, a line of taper is arepresentation of an imaginary conical surface defining a conical taperextending beyond the tapered surface distal edge 1461 of the male luer1441.

In the example of FIGS. 14A-14C, the male luer 1441 further includes aplurality of blades 1463 at the distal tip 1455. Between the blades 1463are a plurality of channels 1467. Blades 1463 and channels 1467 will bediscussed further below.

A number of example implementations will now be described in relation toFIGS. 15A-32G. It should be understood that each example below could becombined with the needleless connector proximal end 1407 to create theneedleless connector 1411. In addition, each of the male connectorsdescribed below are not limited to needleless connectors, and could becombined with other medical devices using luer couplings.

Male Connector with Distal Recess (FIGS. 15A-F & 16)

Turning now to FIGS. 15A-16, a male connector 1501 includes a male luer1541. The male luer 1541 comprises a tapered sealing member 1542. Thetapered sealing member 1542 has a frustoconical shape that tapers from alarger outer diameter at the proximal portion of the tapered sealingmember 1542 to a smaller outer diameter at the distal portion of thetapered sealing member near the tapered surface distal edge 1561. Thetapered sealing member 1542 has a tapered sealing surface 1543 that isconfigured to mate with a female luer to create a fluid tight fit. Themale connector 1501 further includes threads 1502 that allow the maleconnector 1501 to couple with a female connector. A lumen 1512 runsthrough the male connector 1501.

The male luer 1541 includes a distal tip 1555 with an end face 1504. Thedistal tip 1555 of the male luer 1541 is recessed from the distal lineof taper of the tapered sealing member 1542. FIG. 16 is a cross-sectionof the male connector 1501. FIG. 16 illustrates a distal line of taper1614 extending in a straight line from the tapered sealing surface 1543.The distal line of taper 1614 of the tapered sealing member 1542 is arepresentation of an imaginary conical surface defining a conical taperextending beyond the tapered surface distal edge 1561 of the male luer1541. The tapered sealing surface 1543 has a taper angle. In someexamples, the taper angle of the tapered sealing member is between about1.5 degrees and about 2 degrees relative to a central longitudinal axis1610 of the male luer 1541. In some examples, the taper angle is about1.72 degrees relative to the central longitudinal axis 1610 of the maleluer 1541 of the male connector 1501. The conical taper defined by thedistal line of taper 1614 surrounds the central longitudinal axis 1610symmetrically.

The distal line of taper 1614 defines an outer diameter of the extensionof the tapered sealing surface 1543. A distal recess 1551 is a radiallyrecessed portion of the distal tip 1555, meaning that the distal tipsurface 1552 of the distal tip 1555 defines an outer diameter that issmaller than the outer diameter of the extension of the tapered sealingsurface 1543. The distal recess 1551 defines a space that is between thedistal line of taper 1614 and distal tip surface 1552.

FIG. 16 further shows an antimicrobial composition 1621 coating thedistal tip surface 1552 of the distal tip 1555. When the male luer 1541is coupled with a female luer, the distal tip surface 1552 of the distaltip 1555 does not make contact with the inside surface of the femaleluer, and a cavity is formed between the distal tip surface 1552 and thefemale tapered surface, similar to that shown in FIG. 7A. In thiscavity, the antimicrobial composition 1621 is able to disperse withinthe volume created between the distal tip surface 1552 and the femaletapered surface.

The male luer 1541 includes a tapered surface distal edge 1561 thatdefines a proximal end of the distal tip 1555. The tapered surfacedistal edge 1561 is situated at the distalmost end of the taperedsealing surface 1543 such that the proximal edge of the distal tip 1555abuts the tapered surface distal edge 1561. The tapered surface distaledge 1561 has an outer diameter, the proximal edge of the distal tip1555 has an outer diameter, and the outer diameter of the taperedsurface distal edge 1561 is greater than the outer diameter of theproximal edge of the distal tip 1555. Since the tapered surface distaledge 1561 has a larger diameter than any outer diameter along the distaltip 1555, when the male luer 1541 is inserted into a female luer, thetapered surface distal edge 1561 of the tapered sealing member 1542 iscapable of capturing microbes that may have infiltrated the innersurface of the female luer. As described above in relation to FIG. 7A,antimicrobial composition 1621 kills the microbes within the cavitybetween the tapered sealing surface of the female luer and the distaltip surface 1552 of the male luer 1541. In some examples, anantimicrobial composition 1621 is applied to the distal tip surface 1552by coating, spraying, or dipping the distal tip 1555, although othermethods of applying antimicrobial agent are contemplated and are withinthe scope of the technology. In some examples, antimicrobial composition1621 is also applied to the tapered sealing surface 1543. Theantimicrobial composition 1621 can also be applied to the end face 1504.

The distal recess 1551 (the space between the distal tip surface 1552and the female luer surface, not shown) is designed to confine theantimicrobial agent between the inner surface of a female luer and thedistal tip surface 1552 so that microbes are exposed to a highantimicrobial concentration. Confinement is a way to keep theantimicrobial agent within the distal recess region during use, whilefluid is flowing through the lumen 1512. The structure of the distalrecess 1551, which contains no through-channel for fluid flow, decreasesfluid transfer between the lumen 1512 and the distal tip surface 1552.

Male Connector with Blades (FIGS. 17A-F)

Turning now to FIGS. 17A-F, a male connector 1701 includes a male luer1741. The male luer 1741 comprises a tapered sealing member 1742. Thetapered sealing member 1742 has a tapered sealing surface 1743 that isconfigured to mate with a female luer to create a fluid tight fit. Themale connector 1701 further includes threads 1702 that allow the maleconnector 1701 to couple with a female connector. A lumen 1712 runsthrough the male connector 1701.

The male luer 1741 includes a distal tip 1755 with an end face 1704. Thedistal tip 1755 of the male luer 1741 is recessed from the distal lineof taper 1714 of the tapered sealing member 1742. A distal recess 1751is formed by a recessed portion of the distal tip 1755. When the maleluer 1741 is sealed against a female luer and the tapered sealingsurface 1743 forms a fluid tight fit with the inside surface of thefemale luer, the distal tip surface 1752 of the distal tip 1755 does notmake contact with the inside surface of the female luer.

The male luer 1741 includes a tapered surface distal edge 1761 thatdefines a proximal end of the distal tip 1755. The tapered surfacedistal edge 1761 is situated at the distalmost end of the taperedsealing surface 1743. When the male luer 1741 is inserted into a femaleluer, the tapered surface distal edge 1761 of the tapered sealing member1742 is capable of capturing microbes that may have infiltrated theinner surface of the female luer.

In some examples, an antimicrobial agent is applied to the distal tipsurface 1752 by coating, spraying, or dipping the distal tip 1755 withan antimicrobial agent, although other methods of applying antimicrobialagent are contemplated and are within the scope of the technology. Insome examples, antimicrobial agent is also applied to the taperedsealing surface 1743. As described above in relation to FIG. 7A, anantimicrobial agent on the distal tip surface 1752 of the distal tip1755 kills microbes within the distal recess 1751 between the surface ofthe female luer and the distal tip surface 1752.

The male luer 1741 further includes multiple blades 1763 arrayed aroundthe distal tip 1755 of the male luer 1741. In some examples, the blades1763 are arranged substantially parallel to the central longitudinalaxis of the male luer 1741. However, as will be described in furtherdetail below, some embodiments can have blades that are notsubstantially parallel to the central longitudinal axis. Between theblades 1763 are a plurality of channels 1767. In the example of FIG. 17,the blades 1763 are elongated projections arranged around the axis ofthe tapered sealing member 1742, and the channels 1767 are elongatedrecesses disposed between the blades 1763 and running parallel to thelumen 1712. The blades 1763 and channels 1767 form alternating apexes1764 and troughs 1768. The distal tip surface 1752 of the distal tip1755 is defined by the blades 1763 and channels 1767, forming aplurality of blade surfaces. Furthermore, an antimicrobial agent on thedistal tip surface 1752 can be stored within the volumes between theblades 1763. This can increase the amount of antimicrobial agent thatcan be stored on the distal tip 1755 of the male luer 1741.

In some examples, the distal tip 1755 has a length of about 0.060 inches(1.52 mm). The length of the distal tip 1755 is measured perpendicularto the diameter of the distal tip 1755. In some examples, the lumen 1712has an inner diameter of about 0.065 inches (1.65 mm). In some examples,the distal tip 1755 has an outer diameter of about 0.095 inches (2.41mm). In some examples, the wall of the distal tip 1755 has a thicknessof about 0.015 inches (0.38 mm). In some examples, the tapered surfacedistal edge 1761 has an outer diameter of about 0.155 inches (3.94 mm).

At the apex 1764 of the blades 1763, the distal tip 1755 has an outerdiameter of between about 0.148 inches and 0.152 inches. At the trough1768 of the channels 1767, the distal tip 1755 has an outer diameter ofbetween about 0.0118 inches and 0.0121 inches. Thus the difference inouter diameter from the trough 1768 to the apex 1764 is approximately0.030 inches in this example. The distal tip 1755 has a tip length asshown in FIGS. 17A-F is 0.060 inches. In other examples the tip lengthis between about 0.025 and 0.125 inches; in another example the tiplength is between 0.050 and 0.090 inches. The distal tip surface 1752(which includes the surface of the blades) of the distal tip 1755 has asurface area of between about 0.0390 inches squared and 0.0370 inchessquared. A male luer distal tip 1755 without blades 1763 and an outerdiameter equal to the trough diameter has a surface area between about0.0235 inches squared and 0.0215 inches squared. Thus, the blades 1763and channels 1767 increase the surface area of the distal tip 1755 byabout 68 percent. In some examples, increasing the distal tip surface1752 can decrease the amount of antimicrobial that is removed from thedistal tip surface 1752 when the connector is being inserted into aninfusion device.

During insertion of the male luer 1741 into a female luer, portions ofthe distal tip 1755 may come in contact with the inside surface of thefemale luer. The apex 1764 of each blade 1763 may come in contact withthe female luer surface, but the troughs 1768 of the channels 1767 willnot come in contact with the female luer surface. Thus, in comparison tothe tapered surface distal edge 1761, the blades 1763 have a relativelysmaller contacting surface area near the end face 1704 of the distal tip1755. This minimizes the amount of ingress of microbes that can beattributed to microbes being pushed into the body of the female luer bythe blades 1763 compared to the tapered surface distal edge 1761 of themale luer 1741. Thus in some situations there is a greater probabilityof the microbes being located at the tapered surface distal edge 1761compared to the end face 1704. This is desirable because theconcentration of antimicrobial composition will be greater (it will beat a lethal concentration to kill microbes) at the tapered surfacedistal edge 1761 than the end face 1704.

The channels 1767 affect confinement of microbes within the distalrecess 1751 because the channels 1767 provide a restricted space inwhich microbes can be trapped between the distal tip surface 1752 and aninside surface of a female luer. The apex 1764 of the blades 1763provide a maximum outer diameter of the distal tip 1755, and the troughs1768 of the channels 1767 provide a minimum outer diameter of the distaltip 1755. Although some fluid flow between adjacent channels 1767 ispossible when the male luer 1741 is coupled with a female luer, theblades 1763 provide a partial physical barrier. As seen in FIGS. 17D-F,the distal tip 1755 has an outer diameter that is smaller than the outerdiameter of the tapered sealing member 1742 at the tapered surfacedistal edge 1761, and the outer diameter of the distal tip 1755 issmaller than the outer diameter of the distal line of taper 1714 definedby the conical tapered sealing member 1742.

Male Connector with Elongated Blades (FIGS. 18A-F)

Turning now to FIGS. 18A-F, a male connector 1801 includes a male luer1841. The male luer 1841 comprises a tapered sealing member 1842. Thetapered sealing member 1842 has a frustoconical shape that tapers from alarger outer diameter at the proximal portion of the tapered sealingmember 1842 to a smaller outer diameter at the distal portion of thetapered sealing member near the tapered surface distal edge 1861. Thetapered sealing member 1842 has a tapered sealing surface 1843 that isconfigured to mate with a female luer to create a fluid tight fit. Themale connector 1801 further includes threads 1802 that allow the maleconnector 1801 to couple with a female connector. A lumen 1812 runsthrough the male connector 1801.

The male luer 1841 includes a distal tip 1855 with an end face 1804. Thedistal tip 1855 of the male luer 1841 is recessed from the distal lineof taper of the tapered sealing member 1842. A distal recess 1851 isformed by a recessed portion of the distal tip 1855. The distal tipsurface 1852 of the distal tip 1855 defines an outer diameter that issmaller than the outer diameter of the extension of the tapered sealingsurface 1843.

The male luer 1841 includes a tapered surface distal edge 1861 thatdefines a proximal end of the distal tip 1855. The tapered surfacedistal edge 1861 is situated at the distalmost end of the taperedsealing surface 1843. In some examples, an antimicrobial agent isapplied to the distal tip surface 1852 by coating, spraying, or dippingthe distal tip 1855 with an antimicrobial agent, although other methodsof applying antimicrobial agent are contemplated and are within thescope of the technology. In some examples, antimicrobial agent is alsoapplied to the tapered sealing surface 1843. An antimicrobial agent onthe distal tip surface 1852 of the distal tip 1855 kills microbes withinthe distal recess 1851 between the surface of the female luer and thedistal tip surface 1852. The distal recess 1851 is designed to confinethe antimicrobial agent between the inner surface of a female luer andthe distal tip surface 1852 so that microbes are exposed to a highantimicrobial concentration.

The male luer 1841 further includes multiple blades 1863 arrayed aroundthe distal tip 1855 of the male luer 1841. Between the blades 1863 are aplurality of channels 1867. In the example of FIG. 18, the blades 1863are elongated projections arranged around the axis of the taperedsealing member 1842, and the channels 1867 are elongated recessesdisposed between the blades 1863 and running parallel to the lumen 1812.The blades 1863 and channels 1867 form alternating apexes 1864 andtroughs 1868. The distal tip surface 1852 of the distal tip 1855 isdefined by the blades 1863 and channels 1867. An antimicrobial agent onthe distal tip surface 1852 can be stored within the volumes between theblades 1863.

During insertion of the male luer 1841 into a female luer, portions ofthe distal tip 1855 may come in contact with the inside surface of thefemale luer. The apex 1864 of each blade 1863 may come in contact withthe female luer surface, but the troughs 1868 of the channels 1867 willnot come in contact with the female luer surface. Thus, in comparison tothe tapered surface distal edge 1861, the blades 1863 have a relativelysmaller surface area near the end face 1804 of the distal tip 1855. Thisminimizes the amount of ingress of microbes that can be attributed tomicrobes being pushed into the body of the female luer by the male luer1841.

The channels 1867 affect confinement of microbes within the distalrecess because the channels 1867 provide a restricted space in whichmicrobes can be trapped between the distal tip surface 1852 and aninside surface of a female luer. The apex 1864 of the blades 1863provide a maximum outer diameter of the distal tip 1855, and the troughs1868 of the channels 1867 provide a minimum outer diameter of the distaltip 1855. Although some fluid flow between adjacent channels 1867 ispossible when the male luer 1841 is coupled with a female luer, theblades 1863 provide a partial physical barrier. As seen in FIGS. 18D and18E, the distal tip 1855 has an outer diameter that is smaller than theouter diameter of the tapered sealing member 1842 at the tapered surfacedistal edge 1861, and the outer diameter of the distal tip 1855 issmaller than the outer diameter of a distal line of taper defined by theconical tapered sealing member 1842.

The distal tip 1855 has fourteen elongated blades 1863 that extend intothe threaded cavity 1839 of the male connector 1801. The male luer 1841of FIG. 18 has a shorter tapered sealing surface 1843 than the male luer1741 of FIG. 17; however, the distal recess 1851 is longer and thedistal tip surface 1852 of the distal tip 1855 has a greater surfacearea than the example of FIG. 17. In some examples, the length of thedistal tip 1855 as measured perpendicular to the outer diameter of thedistal tip 1855 is between about 0.025 and 0.125 inches (0.64-3.18 mm).

Male Connector with Six Blades (FIGS. 19A-F)

Turning now to FIGS. 19A-F, a male connector 1901 includes a male luer1941. The male luer 1941 comprises a tapered sealing member 1942. Thetapered sealing member 1942 has a frustoconical shape that tapers from alarger outer diameter at the proximal portion of the tapered sealingmember 1942 to a smaller outer diameter at the distal portion of thetapered sealing member near the tapered surface distal edge 1961. Thetapered sealing member 1942 has a tapered sealing surface 1943 that isconfigured to mate with a female luer to create a fluid tight fit. Themale connector 1901 further includes threads 1902 that allow the maleconnector 1901 to couple with a female connector. A lumen 1912 runsthrough the male connector 1901.

The male luer 1941 includes a distal tip 1955 with an end face 1904. Thedistal tip 1955 of the male luer 1941 is recessed from the distal lineof taper of the tapered sealing member 1942. A distal recess 1951 isformed by a recessed portion of the distal tip 1955. The distal tipsurface 1952 of the distal tip 1955 defines an outer diameter that issmaller than the outer diameter of the extension of the tapered sealingsurface 1943.

The male luer 1941 includes a tapered surface distal edge 1961 thatdefines a proximal end of the distal tip 1955. In some examples, anantimicrobial agent is applied to the distal tip surface 1952 bycoating, spraying, or dipping the distal tip 1955 with an antimicrobialagent, although other methods of applying antimicrobial agent arecontemplated and are within the scope of the technology. In someexamples, antimicrobial agent is also applied to the tapered sealingsurface 1943. An antimicrobial agent on the distal tip surface 1952 ofthe distal tip 1955 kills microbes within the distal recess 1951 betweenthe surface of the female luer and the distal tip surface 1952. Thedistal recess 1951 is designed to confine the antimicrobial agentbetween the inner surface of a female luer and the distal tip surface1952 so that microbes are exposed to a high antimicrobial concentration.

The male luer 1941 further includes multiple blades 1963 arrayed aroundthe distal tip 1955 of the male luer 1941. Between the blades 1963 are aplurality of channels 1967. In the example of FIG. 19, the blades 1963are elongated projections arranged around the axis of the taperedsealing member 1942, and the channels 1967 are elongated recessesdisposed between the blades 1963 and running parallel to the lumen 1912.The blades 1963 and channels 1967 form alternating apexes 1964 andtroughs 1968. The distal tip surface 1952 of the distal tip 1955 isdefined by the blades 1963 and channels 1967. An antimicrobial agent onthe distal tip surface 1952 can be stored within the volumes between theblades 1963.

During insertion of the male luer 1941 into a female luer, portions ofthe distal tip 1955 may come in contact with the inside surface of thefemale luer. The apex 1964 of each blade 1963 may come in contact withthe female luer surface, but the troughs 1968 of the channels 1967 willnot come in contact with the female luer surface. Thus, in comparison tothe tapered surface distal edge 1961, the blades 1963 have a relativelysmaller surface area near the end face 1904 of the distal tip 1955. Thisminimizes the amount of ingress of microbes that can be attributed tomicrobes being pushed into the body of the female luer by the male luer1941.

The channels 1967 affect confinement of microbes within the distalrecess because the channels 1967 provide a restricted space in whichmicrobes can be trapped between the distal tip surface 1952 and aninside surface of a female luer. The apex 1964 of the blades 1963provide a maximum outer diameter of the distal tip 1955, and the troughs1968 of the channels 1967 provide a minimum outer diameter of the distaltip 1955. Although some fluid flow between adjacent channels 1967 ispossible when the male luer 1941 is coupled with a female luer, theblades 1963 provide a partial physical barrier. As seen in FIGS. 19D and19E, the distal tip 1955 has an outer diameter that is smaller than theouter diameter of the tapered sealing member 1942 at the tapered surfacedistal edge 1961, and the outer diameter of the distal tip 1955 issmaller than the outer diameter of a distal line of taper defined by theconical tapered sealing member 1942.

The distal tip 1955 of the male luer 1941 has six blades 1963 definingsix channels 1967 with troughs 1968. In the example of FIG. 19C, thetroughs 1968 are curved slightly outward, creating distinct creases 1969at the base of the blades 1963.

Male Connector with Blades and Rounded Distal Tip (FIGS. 20A-G) Turningnow to FIGS. 20A-G, a male connector 2001 includes a male luer 2041. Themale luer 2041 comprises a tapered sealing member 2042. The taperedsealing member 2042 has a frustoconical shape that tapers from a largerouter diameter at the proximal portion of the tapered sealing member2042 to a smaller outer diameter at the distal portion of the taperedsealing member near the tapered surface distal edge 2061. The taperedsealing member 2042 has a tapered sealing surface 2043 that isconfigured to mate with a female luer to create a fluid tight fit. Themale connector 2001 further includes threads 2002 that allow the maleconnector 2001 to couple with a female connector. A lumen 2012 runsthrough the male connector 2001.

The male luer 2041 includes a distal tip 2055 with an end face 2004. Thedistal tip 2055 of the male luer 2041 is recessed from the distal lineof taper of the tapered sealing member 2042. A distal recess 2051 isformed by a recessed portion of the distal tip 2055. The distal tipsurface 2052 of the distal tip 2055 defines an outer diameter that issmaller than the outer diameter of the extension of the tapered sealingsurface 2043.

The male luer 2041 includes a tapered surface distal edge 2061 thatdefines a proximal end of the distal tip 2055. In some examples, anantimicrobial agent is applied to the distal tip surface 2052 bycoating, spraying, or dipping the distal tip 2055 with an antimicrobialagent, although other methods of applying antimicrobial agent arecontemplated and are within the scope of the technology. In someexamples, antimicrobial agent is also applied to the tapered sealingsurface 2043. An antimicrobial agent on the distal tip surface 2052 ofthe distal tip 2055 kills microbes within the distal recess 2051 betweenthe surface of the female luer and the distal tip surface 2052. Thedistal recess 2051 is designed to confine the antimicrobial agentbetween the inner surface of a female luer and the distal tip surface2052 so that microbes are exposed to a high antimicrobial concentration.

The male luer 2041 further includes multiple blades 2063 arrayed aroundthe distal tip 2055 of the male luer 2041. Between the blades 2063 are aplurality of channels 2067. In the example of FIG. 20, the blades 2063are elongated projections arranged around the axis of the taperedsealing member 2042, and the channels 2067 are elongated recessesdisposed between the blades 2063 and running parallel to the lumen 2012.The blades 2063 and channels 2067 form alternating apexes 2064 andtroughs 2068. The distal tip surface 2052 of the distal tip 2055 isdefined by the blades 2063 and channels 2067. An antimicrobial agent onthe distal tip surface 2052 can be stored within the volumes between theblades 2063.

During insertion of the male luer 2041 into a female luer, portions ofthe distal tip 2055 may come in contact with the inside surface of thefemale luer. The apex 2064 of each blade 2063 may come in contact withthe female luer surface, but the troughs 2068 of the channels 2067 willnot come in contact with the female luer surface. Thus, in comparison tothe tapered surface distal edge 2061, the blades 2063 have a relativelysmaller surface area near the end face 2004 of the distal tip 2055. Thisminimizes the amount of ingress of microbes that can be attributed tomicrobes being pushed into the body of the female luer by the male luer2041.

The channels 2067 affect confinement of microbes within the distalrecess because the channels 2067 provide a restricted space in whichmicrobes can be trapped between the distal tip surface 2052 and aninside surface of a female luer. The apex 2064 of the blades 2063provide a maximum outer diameter of the distal tip 2055, and the troughs2068 of the channels 2067 provide a minimum outer diameter of the distaltip 2055. Although some fluid flow between adjacent channels 2067 ispossible when the male luer 2041 is coupled with a female luer, theblades 2063 provide a partial physical barrier. As seen in FIGS. 20E and20F, the distal tip 2055 has an outer diameter that is smaller than theouter diameter of the tapered sealing member 2042 at the tapered surfacedistal edge 2061, and the outer diameter of the distal tip 2055 issmaller than the outer diameter of a distal line of taper defined by theconical tapered sealing member 2042.

The distal tip 2055 has a plurality of blades 2063 separating aplurality of channels 2067. The blades 2063 have rounded blade tips 2082that taper in width from the end face 1904 to the apex 2064 of theblades 2063. This structure makes the distal recess 2051 rounded at theboundary between the distal recess region and the bulk flow region whenthe male luer 2041 is coupled with a female luer.

Male Connector with Enhanced Crevices (FIGS. 21A-F)

Turning now to FIGS. 21A-F, a male connector 2101 includes a male luer2141. The male luer 2141 comprises a tapered sealing member 2142. Thetapered sealing member 2142 has a frustoconical shape that tapers from alarger outer diameter at the proximal portion of the tapered sealingmember 2142 to a smaller outer diameter at the distal portion of thetapered sealing member near the tapered surface distal edge 2161. Thetapered sealing member 2142 has a tapered sealing surface 2143 that isconfigured to mate with a female luer to create a fluid tight fit. Themale connector 2101 further includes threads 2102 that allow the maleconnector 2101 to couple with a female connector. A lumen 2112 runsthrough the male connector 2101.

The male luer 2141 includes a distal tip 2155 with an end face 2104. Thedistal tip 2155 of the male luer 2141 is recessed from the distal lineof taper of the tapered sealing member 2142. A distal recess 2151 isformed by a recessed portion of the distal tip 2155. The distal tipsurface 2152 of the distal tip 2155 defines an outer diameter that issmaller than the outer diameter of the extension of the tapered sealingsurface 2143.

The male luer 2141 includes a tapered surface distal edge 2161 thatdefines a proximal end of the distal tip 2155. In some examples, anantimicrobial agent is applied to the distal tip surface 2152 bycoating, spraying, or dipping the distal tip 2155 with an antimicrobialagent, although other methods of applying antimicrobial agent arecontemplated and are within the scope of the technology. In someexamples, antimicrobial agent is also applied to the tapered sealingsurface 2143. An antimicrobial agent on the distal tip surface 2152 ofthe distal tip 2155 kills microbes within the distal recess 2151 betweenthe surface of the female luer and the distal tip surface 2152. Thedistal recess 2151 is designed to confine the antimicrobial agentbetween the inner surface of a female luer and the distal tip surface2152 so that microbes are exposed to a high antimicrobial concentration.

The male luer 2141 further includes multiple blades 2163 arrayed aroundthe distal tip 2155 of the male luer 2141. Between the blades 2163 are aplurality of channels 2167. In the example of FIG. 21, the blades 2163are elongated projections arranged around the axis of the taperedsealing member 2142, and the channels 2167 are elongated recessesdisposed between the blades 2163 and running parallel to the lumen 2112.The blades 2163 and channels 2167 form alternating apexes 2164 andtroughs 2168. The distal tip surface 2152 of the distal tip 2155 isdefined by the blades 2163 and channels 2167. An antimicrobial agent onthe distal tip surface 2152 can be stored within the volumes between theblades 2163.

During insertion of the male luer 2141 into a female luer, portions ofthe distal tip 2155 may come in contact with the inside surface of thefemale luer. The apex 2164 of each blade 2163 may come in contact withthe female luer surface, but the troughs 2168 of the channels 2167 willnot come in contact with the female luer surface. Thus, in comparison tothe tapered surface distal edge 2161, the blades 2163 have a relativelysmaller surface area near the end face 2104 of the distal tip 2155. Thisminimizes the amount of ingress of microbes that can be attributed tomicrobes being pushed into the body of the female luer by the male luer2141.

The channels 2167 affect confinement of microbes within the distalrecess because the channels 2167 provide a restricted space in whichmicrobes can be trapped between the distal tip surface 2152 and aninside surface of a female luer. The apex 2164 of the blades 2163provide a maximum outer diameter of the distal tip 2155, and the troughs2168 of the channels 2167 provide a minimum outer diameter of the distaltip 2155. Although some fluid flow between adjacent channels 2167 ispossible when the male luer 2141 is coupled with a female luer, theblades 2163 provide a partial physical barrier. As seen in FIGS. 21D and21E, the distal tip 2155 has an outer diameter that is smaller than theouter diameter of the tapered sealing member 2142 at the tapered surfacedistal edge 2161, and the outer diameter of the distal tip 2155 issmaller than the outer diameter of a distal line of taper defined by theconical tapered sealing member 2142.

The distal tip 2155 has a plurality of blades 2163 that separate aplurality of channels 2167. This example shows a large difference inheight from the apex 2164 to the trough 2168. This in turn increases thesurface area on which an antimicrobial agent can be stored. Furthermore,the depth of the channels 2167 allows an increased load of antimicrobialagent to be stored at the distal tip 2155.

Male Connector with Irregular Blade Heights (FIGS. 22A-F)

Turning now to FIGS. 22A-F, a male connector 2201 includes a male luer2241. The male luer 2241 comprises a tapered sealing member 2242. Thetapered sealing member 2242 has a frustoconical shape that tapers from alarger outer diameter at the proximal portion of the tapered sealingmember 2242 to a smaller outer diameter at the distal portion of thetapered sealing member near the tapered surface distal edge 2261. Thetapered sealing member 2242 has a tapered sealing surface 2243 that isconfigured to mate with a female luer to create a fluid tight fit. Themale connector 2201 further includes threads 2202 that allow the maleconnector 2201 to couple with a female connector. A lumen 2212 runsthrough the male connector 2201.

The male luer 2241 includes a distal tip 2255 with an end face 2204. Thedistal tip 2255 of the male luer 2241 is recessed from the distal lineof taper of the tapered sealing member 2242. A distal recess 2251 isformed by a recessed portion of the distal tip 2255. The distal tipsurface 2252 of the distal tip 2255 defines an outer diameter that issmaller than the outer diameter of the extension of the tapered sealingsurface 2243.

The male luer 2241 includes a tapered surface distal edge 2261 thatdefines a proximal end of the distal tip 2255. In some examples, anantimicrobial agent is applied to the distal tip surface 2252 bycoating, spraying, or dipping the distal tip 2255 with an antimicrobialagent, although other methods of applying antimicrobial agent arecontemplated and are within the scope of the technology. In someexamples, antimicrobial agent is also applied to the tapered sealingsurface 2243. An antimicrobial agent on the distal tip surface 2252 ofthe distal tip 2255 kills microbes within the distal recess 2251 betweenthe surface of the female luer and the distal tip surface 2252. Thedistal recess 2251 is designed to confine the antimicrobial agentbetween the inner surface of a female luer and the distal tip surface2252 so that microbes are exposed to a high antimicrobial concentration.

The male luer 2241 further includes multiple blades 2263 arrayed aroundthe distal tip 2255 of the male luer 2241. Between the blades 2263 are aplurality of channels 2267. In the example of FIG. 22, the blades 2263are elongated projections arranged around the axis of the taperedsealing member 2242, and the channels 2267 are elongated recessesdisposed between the blades 2263 and running parallel to the lumen 2212.The blades 2263 and channels 2267 form alternating apexes 2264 andtroughs 2268. The distal tip surface 2252 of the distal tip 2255 isdefined by the blades 2263 and channels 2267. An antimicrobial agent onthe distal tip surface 2252 can be stored within the volumes between theblades 2263.

During insertion of the male luer 2241 into a female luer, portions ofthe distal tip 2255 may come in contact with the inside surface of thefemale luer. The apex 2264 of each high blade 2265 may come in contactwith the female luer surface, but the troughs 2268 of the channels 2267and low blades 2266 will not come in contact with the female luersurface. Thus, in comparison to the tapered surface distal edge 2261,the high blades 2265 have a relatively smaller surface area near the endface 2204 of the distal tip 2255. This minimizes the amount of ingressof microbes that can be attributed to microbes being pushed into thebody of the female luer by the male luer 2241.

The channels 2267 affect confinement of microbes within the distalrecess because the channels 2267 provide a restricted space in whichmicrobes can be trapped between the distal tip surface 2252 and aninside surface of a female luer. The apex 2264 of the blades 2263provide a maximum outer diameter of the distal tip 2255, and the troughs2268 of the channels 2267 provide a minimum outer diameter of the distaltip 2255. Although some fluid flow between adjacent channels 2267 ispossible when the male luer 2241 is coupled with a female luer, theblades 2263 provide a partial physical barrier. As seen in FIGS. 22D and22E, the distal tip 2255 has an outer diameter that is smaller than theouter diameter of the tapered sealing member 2242 at the tapered surfacedistal edge 2261, and the outer diameter of the distal tip 2255 issmaller than the outer diameter of a distal line of taper defined by theconical tapered sealing member 2242.

The distal tip 2255 has a plurality of blades 2263 that separate aplurality of channels 2267. In this example, the distal tip 2255includes high blades 2265 and low blades 2266. The high blades 2265 havea greater outer diameter than the outer diameter of the low blades 2266.In this example, the troughs 2268 of the channels 2267 each have thesame outer diameter. As can be seen in FIG. 22D, in this example, eachhigh blade 2265 is 180° opposite a low blade 2266. As seen in FIG. 22E,the male luer 2241 has a tapered surface distal edge 2261, and the apexof a blade 2263 is inside the line of taper such that the outer diameterof the blade 2263 is less than the outer diameter of the tapered surfacedistal edge 2261.

Male Connector with Irregular Blade Heights (FIGS. 23A-G)

Turning now to FIGS. 23A-G, a male connector 2301 includes a male luer2341. The male luer 2341 comprises a tapered sealing member 2342. Thetapered sealing member 2342 has a frustoconical shape that tapers from alarger outer diameter at the proximal portion of the tapered sealingmember 2342 to a smaller outer diameter at the distal portion of thetapered sealing member near the tapered surface distal edge 2361. Thetapered sealing member 2342 has a tapered sealing surface 2343 that isconfigured to mate with a female luer to create a fluid tight fit. Themale connector 2301 further includes threads 2302 that allow the maleconnector 2301 to couple with a female connector. A lumen 2312 runsthrough the male connector 2301.

The male luer 2341 includes a distal tip 2355 with an end face 2304. Thedistal tip 2355 of the male luer 2341 is recessed from the distal lineof taper of the tapered sealing member 2342. A distal recess 2351 isformed by a recessed portion of the distal tip 2355. The distal tipsurface 2352 of the distal tip 2355 defines an outer diameter that issmaller than the outer diameter of the extension of the tapered sealingsurface 2343.

The male luer 2341 includes a tapered surface distal edge 2361 thatdefines a proximal end of the distal tip 2355. In some examples, anantimicrobial agent is applied to the distal tip surface 2352 bycoating, spraying, or dipping the distal tip 2355 with an antimicrobialagent, although other methods of applying antimicrobial agent arecontemplated and are within the scope of the technology. In someexamples, antimicrobial agent is also applied to the tapered sealingsurface 2343. An antimicrobial agent on the distal tip surface 2352 ofthe distal tip 2355 kills microbes within the distal recess 2351 betweenthe surface of the female luer and the distal tip surface 2352. Thedistal recess 2351 is designed to confine the antimicrobial agentbetween the inner surface of a female luer and the distal tip surface2352 so that microbes are exposed to a high antimicrobial concentration.

The male luer 2341 further includes multiple blades 2363 arrayed aroundthe distal tip 2355 of the male luer 2341. Between the blades 2363 are aplurality of channels 2367. In the example of FIG. 23, the blades 2363are elongated projections arranged around the axis of the taperedsealing member 2342, and the channels 2367 are elongated recessesdisposed between the blades 2363 and running parallel to the lumen 2312.The blades 2363 and channels 2367 form alternating apexes 2364 andtroughs 2368. The distal tip surface 2352 of the distal tip 2355 isdefined by the blades 2363 and channels 2367. An antimicrobial agent onthe distal tip surface 2352 can be stored within the volumes between theblades 2363.

The distal tip 2355 has a plurality of blades 2363 that separate aplurality of channels 2367. In this example, the distal tip 2355includes high blades 2365 and low blades 2366. The high blades 2365 havea greater outer diameter than the outer diameter of the low blades 2366.As seen in FIG. 23E, the male luer 2341 has a tapered surface distaledge 2361, and the apex 2364 of blade 2363 is inside the line of tapersuch that the outer diameter of the blade 2363 is less than the outerdiameter of the tapered surface distal edge 2361.

During insertion of the male luer 2341 into a female luer, portions ofthe distal tip 2355 may come in contact with the inside surface of thefemale luer. The apex 2364 of each high blade 2365 may come in contactwith the female luer surface, but the troughs 2368 of the channels 2367and low blades 2366 will not come in contact with the female luersurface. Thus, in comparison to the tapered surface distal edge 2361,the high blades 2365 have a relatively smaller surface area near the endface 2304 of the distal tip 2355. This minimizes the amount of ingressof microbes that can be attributed to microbes being pushed into thebody of the female luer by the male luer 2341.

The channels 2367 affect confinement of microbes within the distalrecess because the channels 2367 provide a restricted space in whichmicrobes can be trapped between the distal tip surface 2352 and aninside surface of a female luer. The apex 2364 of the blades 2363provide a maximum outer diameter of the distal tip 2355, and the troughs2368 of the channels 2367 provide a minimum outer diameter of the distaltip 2355. Although some fluid flow between adjacent channels 2367 ispossible when the male luer 2341 is coupled with a female luer, theblades 2363 provide a partial physical barrier. As seen in FIGS. 23D and23E, the distal tip 2355 has an outer diameter that is smaller than theouter diameter of the tapered sealing member 2342 at the tapered surfacedistal edge 2361, and the outer diameter of the distal tip 2355 issmaller than the outer diameter of a distal line of taper defined by theconical tapered sealing member 2342.

Male Connector with Tapered Blades and Channels (FIGS. 24A-F)

Turning now to FIGS. 24A-F, a male connector 2401 includes a male luer2441. The male luer 2441 comprises a tapered sealing member 2442. Thetapered sealing member 2442 has a frustoconical shape that tapers from alarger outer diameter at the proximal portion of the tapered sealingmember 2442 to a smaller outer diameter at the distal portion of thetapered sealing member near the tapered surface distal edge 2461. Thetapered sealing member 2442 has a tapered sealing surface 2443 that isconfigured to mate with a female luer to create a fluid tight fit. Themale connector 2401 further includes threads 2402 that allow the maleconnector 2401 to couple with a female connector. A lumen 2412 runsthrough the male connector 2401.

The male luer 2441 includes a distal tip 2455 with an end face 2404. Thedistal tip 2455 of the male luer 2441 is recessed from the distal lineof taper of the tapered sealing member 2442. A distal recess 2451 isformed by a recessed portion of the distal tip 2455. The distal tipsurface 2452 of the distal tip 2455 defines an outer diameter that issmaller than the outer diameter of the extension of the tapered sealingsurface 2443.

The male luer 2441 includes a tapered surface distal edge 2461 thatdefines a proximal end of the distal tip 2455. In some examples, anantimicrobial agent is applied to the distal tip surface 2452 bycoating, spraying, or dipping the distal tip 2455 with an antimicrobialagent, although other methods of applying antimicrobial agent arecontemplated and are within the scope of the technology. In someexamples, antimicrobial agent is also applied to the tapered sealingsurface 2443. An antimicrobial agent on the distal tip surface 2452 ofthe distal tip 2455 kills microbes within the distal recess 2451 betweenthe surface of the female luer and the distal tip surface 2452. Thedistal recess 2451 is designed to confine the antimicrobial agentbetween the inner surface of a female luer and the distal tip surface2452 so that microbes are exposed to a high antimicrobial concentration.

The male luer 2441 further includes multiple blades 2463 arrayed aroundthe distal tip 2455 of the male luer 2441. Between the blades 2463 are aplurality of channels 2467. In the example of FIG. 24, the blades 2463are elongated projections arranged around the axis of the taperedsealing member 2442, and the channels 2467 are elongated recessesdisposed between the blades 2463 and running parallel to the lumen 2412.The blades 2463 and channels 2467 form alternating apexes 2464 andtroughs 2468. The distal tip surface 2452 of the distal tip 2455 isdefined by the blades 2463 and channels 2467. An antimicrobial agent onthe distal tip surface 2452 can be stored within the volumes between theblades 2463.

During insertion of the male luer 2441 into a female luer, portions ofthe distal tip 2455 may come in contact with the inside surface of thefemale luer. The apex 2464 of each blade 2463 may come in contact withthe female luer surface, but the troughs 2468 of the channels 2467 willnot come in contact with the female luer surface. Thus, in comparison tothe tapered surface distal edge 2461, the blades 2463 have a relativelysmaller surface area near the end face 2404 of the distal tip 2455. Thisminimizes the amount of ingress of microbes that can be attributed tomicrobes being pushed into the body of the female luer by the male luer2441.

The channels 2467 affect confinement of microbes within the distalrecess because the channels 2467 provide a restricted space in whichmicrobes can be trapped between the distal tip surface 2452 and aninside surface of a female luer. The apex 2464 of the blades 2463provide a maximum outer diameter of the distal tip 2455, and the troughs2468 of the channels 2467 provide a minimum outer diameter of the distaltip 2455. Although some fluid flow between adjacent channels 2467 ispossible when the male luer 2441 is coupled with a female luer, theblades 2463 provide a partial physical barrier. As seen in FIGS. 24F and24G, the distal tip 2455 has an outer diameter that is smaller than theouter diameter of the tapered sealing member 2442 at the tapered surfacedistal edge 2461, and the outer diameter of the distal tip 2455 smallerthan the outer diameter of a distal line of taper defined by the conicaltapered sealing member 2442.

The distal tip 2455 has a plurality of blades 2463 separating aplurality of channels 2467. The blades 2463 have an apex 2464, and thechannels 2467 have troughs 2468. In this example, the outer diameter ofthe apex 2464 is uniform, but the width of the blades 2463 increasestoward the end face 2404 of the distal tip 2455. The outer diameter ofthe troughs 2468 decreases from the proximal portion to the distalportion of the distal tip 2455, causing the taper in the trough 2468seen in FIG. 24H.

Male Connector with Blade Apex Taper (FIGS. 25A-G)

Turning now to FIGS. 25A-G, a male connector 2501 includes a male luer2541. The male luer 2541 comprises a tapered sealing member 2542. Thetapered sealing member 2542 has a frustoconical shape that tapers from alarger outer diameter at the proximal portion of the tapered sealingmember 2542 to a smaller outer diameter at the distal portion of thetapered sealing member near the tapered surface distal edge 2561. Thetapered sealing member 2542 has a tapered sealing surface 2543 that isconfigured to mate with a female luer to create a fluid tight fit. Themale connector 2501 further includes threads 2502 that allow the maleconnector 2501 to couple with a female connector. A lumen 2512 runsthrough the male connector 2501.

The male luer 2541 includes a distal tip 2555 with an end face 2504. Thedistal tip 2555 of the male luer 2541 is recessed from the distal lineof taper of the tapered sealing member 2542. A distal recess 2551 isformed by a recessed portion of the distal tip 2555. The distal tipsurface 2552 of the distal tip 2555 defines an outer diameter that issmaller than the outer diameter of the extension of the tapered sealingsurface 2543.

The male luer 2541 includes a tapered surface distal edge 2561 thatdefines a proximal end of the distal tip 2555. In some examples, anantimicrobial agent is applied to the distal tip surface 2552 bycoating, spraying, or dipping the distal tip 2555 with an antimicrobialagent, although other methods of applying antimicrobial agent arecontemplated and are within the scope of the technology. In someexamples, antimicrobial agent is also applied to the tapered sealingsurface 2543. An antimicrobial agent on the distal tip surface 2552 ofthe distal tip 2555 kills microbes within the distal recess 2551 betweenthe surface of the female luer and the distal tip surface 2552. Thedistal recess 2551 is designed to confine the antimicrobial agentbetween the inner surface of a female luer and the distal tip surface2552 so that microbes are exposed to a high antimicrobial concentration.

The male luer 2541 further includes multiple blades 2563 arrayed aroundthe distal tip 2555 of the male luer 2541. Between the blades 2563 are aplurality of channels 2567. In the example of FIG. 25, the blades 2563are elongated projections arranged around the axis of the taperedsealing member 2542, and the channels 2567 are elongated recessesdisposed between the blades 2563 and running parallel to the lumen 2512.The blades 2563 and channels 2567 form alternating apexes 2564 andtroughs 2568. The distal tip surface 2552 of the distal tip 2555 isdefined by the blades 2563 and channels 2567. An antimicrobial agent onthe distal tip surface 2552 can be stored within the volumes between theblades 2563.

During insertion of the male luer 2541 into a female luer, portions ofthe distal tip 2555 may come in contact with the inside surface of thefemale luer. The apex 2564 of each blade 2563 may come in contact withthe female luer surface, but the troughs 2568 of the channels 2567 willnot come in contact with the female luer surface. Thus, in comparison tothe tapered surface distal edge 2561, the blades 2563 have a relativelysmaller surface area near the end face 2504 of the distal tip 2555. Thisminimizes the amount of ingress of microbes that can be attributed tomicrobes being pushed into the body of the female luer by the male luer2541.

The channels 2567 affect confinement of microbes within the distalrecess because the channels 2567 provide a restricted space in whichmicrobes can be trapped between the distal tip surface 2552 and aninside surface of a female luer. The apex 2564 of the blades 2563provide a maximum outer diameter of the distal tip 2555, and the troughs2568 of the channels 2567 provide a minimum outer diameter of the distaltip 2555. Although some fluid flow between adjacent channels 2567 ispossible when the male luer 2541 is coupled with a female luer, theblades 2563 provide a partial physical barrier. As seen in FIGS. 25E and25F, the distal tip 2555 has an outer diameter that is smaller than theouter diameter of the tapered sealing member 2542 at the tapered surfacedistal edge 2561, and the outer diameter of the distal tip 2555 issmaller than the outer diameter of a distal line of taper defined by theconical tapered sealing member 2542.

The distal tip 2555 has a plurality of blades 2563 separating aplurality of channels 2567. In this example, both the apex 2564 of theblades 2563 and the troughs 2568 of the channels 2567 are tapered suchthat the outer diameter decreases toward the end face 2504 of the distaltip 2555.

Male Connector with Distal Blade Taper (FIGS. 26A-G)

Turning now to FIGS. 26A-G, a male connector 2601 includes a male luer2641. The male luer 2641 comprises a tapered sealing member 2642. Thetapered sealing member 2642 has a frustoconical shape that tapers from alarger outer diameter at the proximal portion of the tapered sealingmember 2642 to a smaller outer diameter at the distal portion of thetapered sealing member near the tapered surface distal edge 2661. Thetapered sealing member 2642 has a tapered sealing surface 2643 that isconfigured to mate with a female luer to create a fluid tight fit. Themale connector 2601 further includes threads 2602 that allow the maleconnector 2601 to couple with a female connector. A lumen 2612 runsthrough the male connector 2601.

The male luer 2641 includes a distal tip 2655 with an end face 2604. Thedistal tip 2655 of the male luer 2641 is recessed from the distal lineof taper of the tapered sealing member 2642. A distal recess 2651 isformed by a recessed portion of the distal tip 2655. The distal tipsurface 2652 of the distal tip 2655 defines an outer diameter that issmaller than the outer diameter of the extension of the tapered sealingsurface 2643.

The male luer 2641 includes a tapered surface distal edge 2661 thatdefines a proximal end of the distal tip 2655. In some examples, anantimicrobial agent is applied to the distal tip surface 2652 bycoating, spraying, or dipping the distal tip 2655 with an antimicrobialagent, although other methods of applying antimicrobial agent arecontemplated and are within the scope of the technology. In someexamples, antimicrobial agent is also applied to the tapered sealingsurface 2643. An antimicrobial agent on the distal tip surface 2652 ofthe distal tip 2655 kills microbes within the distal recess 2651 betweenthe surface of the female luer and the distal tip surface 2652. Thedistal recess 2651 is designed to confine the antimicrobial agentbetween the inner surface of a female luer and the distal tip surface2652 so that microbes are exposed to a high antimicrobial concentration.

The male luer 2641 further includes multiple blades 2663 arrayed aroundthe distal tip 2655 of the male luer 2641. Between the blades 2663 are aplurality of channels 2667. In the example of FIG. 26, the blades 2663are elongated projections arranged around the axis of the taperedsealing member 2642, and the channels 2667 are elongated recessesdisposed between the blades 2663 and running parallel to the lumen 2612.The blades 2663 and channels 2667 form alternating apexes 2664 andtroughs 2668. The distal tip surface 2652 of the distal tip 2655 isdefined by the blades 2663 and channels 2667. An antimicrobial agent onthe distal tip surface 2652 can be stored within the volumes between theblades 2663.

During insertion of the male luer 2641 into a female luer, portions ofthe distal tip 2655 may come in contact with the inside surface of thefemale luer. The apex 2664 of each blade 2663 may come in contact withthe female luer surface, but the troughs 2668 of the channels 2667 willnot come in contact with the female luer surface. Thus, in comparison tothe tapered surface distal edge 2661, the blades 2663 have a relativelysmaller surface area near the end face 2604 of the distal tip 2655. Thisminimizes the amount of ingress of microbes that can be attributed tomicrobes being pushed into the body of the female luer by the male luer2641.

The channels 2667 affect confinement of microbes within the distalrecess because the channels 2667 provide a restricted space in whichmicrobes can be trapped between the distal tip surface 2652 and aninside surface of a female luer. The apex 2664 of the blades 2663provide a maximum outer diameter of the distal tip 2655, and the troughs2668 of the channels 2667 provide a minimum outer diameter of the distaltip 2655. Although some fluid flow between adjacent channels 2667 ispossible when the male luer 2641 is coupled with a female luer, theblades 2663 provide a partial physical barrier. As seen in FIGS. 26E and26F, the distal tip 2655 has an outer diameter that is smaller than theouter diameter of the tapered sealing member 2642 at the tapered surfacedistal edge 2661, and the outer diameter of the distal tip 2655 issmaller than the outer diameter of a distal line of taper defined by theconical tapered sealing member 2642.

The distal tip 2655 has a plurality of blades 2663 separating aplurality of channels 2667. In this example, the base of the blades 2663are wide at a proximal end of the distal tip 2655 and gradually tapersuch that the blades 2663 are narrow at a distal end of the distal tip2655. Conversely, the channels 2667 are narrow at the proximal end andwiden toward the distal end of the distal tip 2655. In some examples,the blades 2663 include a bevel 2669 at the distal end.

Male Connector with Irregular Blade Length (FIGS. 27A-G)

Turning now to FIGS. 27A-G, a male connector 2701 includes a male luer2741. The male luer 2741 comprises a tapered sealing member 2742. Thetapered sealing member 2742 has a frustoconical shape that tapers from alarger outer diameter at the proximal portion of the tapered sealingmember 2742 to a smaller outer diameter at the distal portion of thetapered sealing member near the tapered surface distal edge 2761. Thetapered sealing member 2742 has a tapered sealing surface 2743 that isconfigured to mate with a female luer to create a fluid tight fit. Themale connector 2701 further includes threads 2702 that allow the maleconnector 2701 to couple with a female connector. A lumen 2712 runsthrough the male connector 2701.

The male luer 2741 includes a distal tip 2755 with an end face 2704. Thedistal tip 2755 of the male luer 2741 is recessed from the distal lineof taper of the tapered sealing member 2742. A distal recess 2751 isformed by a recessed portion of the distal tip 2755. The distal tipsurface 2752 of the distal tip 2755 defines an outer diameter that issmaller than the outer diameter of the extension of the tapered sealingsurface 2743.

The male luer 2741 includes a tapered surface distal edge 2761 thatdefines a proximal end of the distal tip 2755. In some examples, anantimicrobial agent is applied to the distal tip surface 2752 bycoating, spraying, or dipping the distal tip 2755 with an antimicrobialagent, although other methods of applying antimicrobial agent arecontemplated and are within the scope of the technology. In someexamples, antimicrobial agent is also applied to the tapered sealingsurface 2743. An antimicrobial agent on the distal tip surface 2752 ofthe distal tip 2755 kills microbes within the distal recess 2751 betweenthe surface of the female luer and the distal tip surface 2752. Thedistal recess 2751 is designed to confine the antimicrobial agentbetween the inner surface of a female luer and the distal tip surface2752 so that microbes are exposed to a high antimicrobial concentration.

The male luer 2741 further includes multiple blades 2763 arrayed aroundthe distal tip 2755 of the male luer 2741. Between the blades 2763 are aplurality of channels 2767. In the example of FIG. 27, the blades 2763are elongated projections arranged around the axis of the taperedsealing member 2742, and the channels 2767 are elongated recessesdisposed between the blades 2763 and running parallel to the lumen 2712.The blades 2763 and channels 2767 form alternating apexes 2764 andtroughs 2768. The distal tip surface 2752 of the distal tip 2755 isdefined by the blades 2763 and channels 2767. An antimicrobial agent onthe distal tip surface 2752 can be stored within the volumes between theblades 2763.

During insertion of the male luer 2741 into a female luer, portions ofthe distal tip 2755 may come in contact with the inside surface of thefemale luer. The apex 2764 of each blade 2763 may come in contact withthe female luer surface, but the troughs 2768 of the channels 2767 willnot come in contact with the female luer surface. Thus, in comparison tothe tapered surface distal edge 2761, the blades 2763 have a relativelysmaller surface area near the end face 2704 of the distal tip 2755. Thisminimizes the amount of ingress of microbes that can be attributed tomicrobes being pushed into the body of the female luer by the male luer2741.

The channels 2767 affect confinement of microbes within the distalrecess because the channels 2767 provide a restricted space in whichmicrobes can be trapped between the distal tip surface 2752 and aninside surface of a female luer. The apex 2764 of the blades 2763provide a maximum outer diameter of the distal tip 2755, and the troughs2768 of the channels 2767 provide a minimum outer diameter of the distaltip 2755. Although some fluid flow between adjacent channels 2767 ispossible when the male luer 2741 is coupled with a female luer, theblades 2763 provide a partial physical barrier. As seen in FIGS. 27E and27F, the distal tip 2755 has an outer diameter that is smaller than theouter diameter of the tapered sealing member 2742 at the tapered surfacedistal edge 2761, and the outer diameter of the distal tip 2755 issmaller than the outer diameter of a distal line of taper defined by theconical tapered sealing member 2742.

In this example, the distal tip 2755 includes a plurality of elongatedblades 2765 and a plurality of truncated blades 2766.

Male Connector with Zero-Clearance Blades (FIGS. 28A-F)

Turning now to FIGS. 28A-F, a male connector 2801 includes a male luer2841. The male luer 2841 comprises a tapered sealing member 2842. Thetapered sealing member 2842 has a frustoconical shape that tapers from alarger outer diameter at the proximal portion of the tapered sealingmember 2842 to a smaller outer diameter at the distal portion of thetapered sealing member near the tapered surface distal edge 2861. Thetapered sealing member 2842 has a tapered sealing surface 2843 that isconfigured to mate with a female luer to create a fluid tight fit. Themale connector 2801 further includes threads 2802 that allow the maleconnector 2801 to couple with a female connector. A lumen 2812 runsthrough the male connector 2801.

The male luer 2841 includes a distal tip 2855 with an end face 2804. Asseen in FIG. 28F, a distal recess 2851 is formed by a recessed portionof the distal tip 2855.

The male luer 2841 includes a tapered surface distal edge 2861 thatdefines a proximal end of the distal tip 2855. In some examples, anantimicrobial agent is applied to the distal tip surface 2852 bycoating, spraying, or dipping the distal tip 2855 with an antimicrobialagent, although other methods of applying antimicrobial agent arecontemplated and are within the scope of the technology. In someexamples, antimicrobial agent is also applied to the tapered sealingsurface 2843. An antimicrobial agent on the distal tip surface 2852 ofthe distal tip 2855 kills microbes captured between the surface of thefemale luer and the distal tip surface 2852. The distal recess 2851 isdesigned to confine the antimicrobial agent between the inner surface ofa female luer and the distal tip surface 2852 so that microbes areexposed to a high antimicrobial concentration.

The male luer 2841 further includes multiple blades 2863 arrayed aroundthe distal tip 2855 of the male luer 2841. Between the blades 2863 are aplurality of channels 2867. In the example of FIG. 28, the blades 2863are elongated projections arranged around the axis of the taperedsealing member 2842, and the channels 2867 are elongated recessesdisposed between the blades 2863 and running parallel to the lumen 2812.The blades 2863 and channels 2867 form alternating apexes 2864 andtroughs 2868. The distal tip surface 2852 of the distal tip 2855 isdefined by the blades 2863 and channels 2867. An antimicrobial agent onthe distal tip surface 2852 can be stored within the volumes between theblades 2863.

During insertion of the male luer 2841 into a female luer, portions ofthe distal tip 2855 may come in contact with the inside surface of thefemale luer. The apex 2864 of each blade 2863 may come in contact withthe female luer surface, but the troughs 2868 of the channels 2867 willnot come in contact with the female luer surface. Thus, in comparison tothe tapered surface distal edge 2861, the blades 2863 have a relativelysmaller surface area near the end face 2804 of the distal tip 2855. Thisminimizes the amount of ingress of microbes that can be attributed tomicrobes being pushed into the body of the female luer by the male luer2841.

The channels 2867 affect confinement of microbes within the distalrecess because the channels 2867 provide a restricted space in whichmicrobes can be trapped between the distal tip surface 2852 and aninside surface of a female luer. The apex 2864 of the blades 2863provide a maximum outer diameter of the distal tip 2855, and the troughs2868 of the channels 2867 provide a minimum outer diameter of the distaltip 2855. The blades 2863 provide a physical barrier between adjacentchannels 2867 when the male luer 2841 s mated with a female luer. Asseen in FIGS. 28D and 28E, the outer diameter of the distal tip 2855 isthe same as the outer diameter of the tapered sealing member 2842 at theapex 2864 of the blades 2863. As seen in FIG. 28F, the outer diameter ofthe distal tip 2855 is smaller than the outer diameter of the taperedsealing member 2842 at the trough 2868 of the channels 2867.

In this example, the apex 2864 of each blade 2863 has an outer diameterthat follows the line of taper of the tapered sealing member 2842. Whenthe male connector 2801 is coupled with a female connector such that themale and female luers form a fluid tight fit, the apex 2864 of eachblade 2863 contacts the inner surface of the female luer.

The distal tip 2855 includes a distal recess 2851. In this example, thedistal recess is present inside of the volume of the channels 2867created between the blades 2863, where the outer diameter of the distaltip 2855 is inside the line of taper of the tapered sealing member 2842.

Male Connector with Threaded Blades (FIGS. 29A-G)

Turning now to FIGS. 29A-G, a male connector 2901 includes a male luer2941. The male luer 2941 comprises a tapered sealing member 2942. Thetapered sealing member 2942 has a frustoconical shape that tapers from alarger outer diameter at the proximal portion of the tapered sealingmember 2942 to a smaller outer diameter at the distal portion of thetapered sealing member near the tapered surface distal edge 2961. Thetapered sealing member 2942 has a tapered sealing surface 2943 that isconfigured to mate with a female luer to create a fluid tight fit. Themale connector 2901 further includes threads 2902 that allow the maleconnector 2901 to couple with a female connector. A lumen 2912 runsthrough the male connector 2901.

The male luer 2941 includes a distal tip 2955 with an end face 2904. Asseen in FIGS. 29F and 29G, a distal recess 2951 is formed by a recessedportion of the distal tip 2955.

The male luer 2941 includes a tapered surface distal edge 2961 thatdefines a proximal end of the distal tip 2955. In some examples, anantimicrobial agent is applied to the distal tip surface 2952 bycoating, spraying, or dipping the distal tip 2955 with an antimicrobialagent, although other methods of applying antimicrobial agent arecontemplated and are within the scope of the technology. In someexamples, antimicrobial agent is also applied to the tapered sealingsurface 2943. An antimicrobial agent on the distal tip surface 2952 ofthe distal tip 2955 kills microbes captured between the surface of thefemale luer and the distal tip surface 2952. The distal recess 2951 isdesigned to confine the antimicrobial agent between the inner surface ofa female luer and the distal tip surface 2952 so that microbes areexposed to a high antimicrobial concentration.

An antimicrobial agent on the distal tip surface 2952 can be storedwithin the volumes between the blades 2963.

The distal tip 2955 includes a plurality of blades 2963 that separate aplurality of channels 2967. The blades 2963 spiral around the axis ofthe lumen 2912, and the troughs 2968 of the channels 2967 follow thespiral. In this example, the apex 2964 of each blade 2963 has an outerdiameter that follows the line of taper of the tapered sealing member2942. Thus, when the male connector 2901 is coupled with a femaleconnector such that the male and female luers form a fluid tight fit,the apex 2964 of each blade 2963 contacts the inner surface of thefemale luer.

In some examples, the blades 2963 have a threaded pitch that is the sameas the pitch of the threads 2902 inside of the male connector 2901.Rotating the male connector 2901 around the axis of the lumen 2912 wheninserting the male luer 2941 into a female luer causes the blades 2963to rotate along with the male luer 2941. From the perspective shown inFIG. 29E, the male connector 2901 would move in a counterclockwisedirection. The blades 2963 have a leading edge 2981 that can contact thefemale luer inside surface. In this case, the apex 2964 serves as anextension of the tapered surface distal edge 2961. This rotation canallow the leading edge 2981 of the blades 2963 to act like a ramp,pushing any particles (such as microbes) on the surface of the femaleluer in a proximal direction.

The distal tip 2955 includes a distal recess 2951. In this example, thedistal recess 2951 is present inside of the volume of the channels 2967created between the blades 2963. As noted above, the leading edge 2981can act as a ramp to push particles in a proximal direction, away fromthe end face 2904 of the distal tip 2955. An antimicrobial agent presenton the distal tip surface 2952 of the distal tip 2955 can be dispersedinside the channels 2967 that form the distal recess 2951.

The channels 2967 affect confinement of microbes within the distalrecess 2951 because the channels 2967 provide a restricted space inwhich microbes can be trapped between the distal tip surface 2952 and aninside surface of a female luer. The apex 2964 of the blades 2963provide a maximum outer diameter of the distal tip 2955, and the troughs2968 of the channels 2967 provide a minimum outer diameter of the distaltip 2955. The blades 2963 provide a physical barrier between adjacentchannels 2967 when the male luer 2941 is mated with a female luer. Theouter diameter of the distal tip 2955 is the same as the outer diameterof the tapered sealing member 2942 at the apex 2964 of the blades 2963.As seen in FIGS. 29F and 29G, the outer diameter of the distal tip 2955is smaller than the outer diameter of the tapered sealing member 2942 atthe trough 2968 of the channels 2967.

Male Connector with Proximal Trap (FIGS. 30A-F)

Turning now to FIGS. 30A-F, a male connector 3001 includes a male luer3041. The male luer 3041 comprises a tapered sealing member 3042. Thetapered sealing member 3042 has a frustoconical shape that tapers from alarger outer diameter at the proximal portion of the tapered sealingmember 3042 to a smaller outer diameter at the distal portion of thetapered sealing member near the tapered surface distal edge 3061. Thetapered sealing member 3042 has a tapered sealing surface 3043 that isconfigured to mate with a female luer to create a fluid tight fit. Themale connector 3001 further includes threads 3002 that allow the maleconnector 3001 to couple with a female connector. A lumen 3012 runsthrough the male connector 3001.

The male luer 3041 includes a distal tip 3055 with an end face 3004. Thedistal tip 3055 of the male luer 3041 is recessed from the distal lineof taper of the tapered sealing member 3042. A distal recess 3051 isformed by a recessed portion of the distal tip 3055. The distal tipsurface 3052 of the distal tip 3055 defines an outer diameter that issmaller than the outer diameter of the extension of the tapered sealingsurface 3043.

In some examples, an antimicrobial agent is applied to the distal tipsurface 3052 by coating, spraying, or dipping the distal tip 3055 withan antimicrobial agent, although other methods of applying antimicrobialagent are contemplated and are within the scope of the technology. Insome examples, antimicrobial agent is also applied to the taperedsealing surface 3043. An antimicrobial agent on the distal tip surface3052 of the distal tip 3055 kills microbes within the distal recess 3051between the surface of the female luer and the distal tip surface 3052.The distal recess 3051 is designed to confine the antimicrobial agentbetween the inner surface of a female luer and the distal tip surface3052 so that microbes are exposed to a high antimicrobial concentration.

The distal recess 3051 affects confinement of microbes because thedistal recess 3051 provides a restricted space in which microbes can betrapped between the distal tip surface 3052 and an inside surface of afemale luer. As seen in FIGS. 30E and 30F, the distal tip 3055 has anouter diameter that is smaller than the outer diameter of the taperedsealing member 3042 at the tapered surface distal edge 3061, and theouter diameter of the distal tip 3055 is smaller than the outer diameterof a distal line of taper defined by the conical tapered sealing member3042.

The distal tip 3055 has a distal tip surface 3052 and a distal recess3051. In this example, the distal tip surface 3052 does not includeblades. The male luer 3041 has a tapered surface distal edge 3061 at adistal end of the tapered sealing member 3042. The tapered surfacedistal edge 3061 has a tapered surface distal edge face 3062. A proximaltrap 3071 is defined between the distal tip surface 3052 and theproximal trap walls 3073. The proximal trap 3071 is a cavity that isbounded on multiple sides. The proximal trap 3071 opens on the distalrecess 3051. The proximal trap is adjacent to the tapered surface distaledge face 3062. As will be discussed below in relation to FIGS. 38 and39, an antimicrobial agent can be contained inside of the proximal trap3071.

The proximal trap 3071 stores an antimicrobial agent within the annularcavity defined by the proximal trap 3071. In some examples, microbesreside near the interface between the tapered surface distal edge 3061and a surface of a female luer. The antimicrobial agent stored in theproximal trap 3071 ensures that the concentration of the antimicrobialagent remains high (up to the level of saturation) in the vicinity ofmicrobes.

Both the proximal trap 3071 and the distal recess 3051 are designed tominimize washout of the antimicrobial agent from the volume createdbetween the female luer surface and the distal tip surface 3052. Theproximal trap 3071 has no separate entrance and exit. The antimicrobialagent on the surface of the proximal trap wall 3073 will diffuse out ofthe proximal trap 3071 after the male luer 3041 has been installedinside a female luer. There are differences between confinement ofmicrobes and washout of the antimicrobial agent from the distal recess3051. Confinement keeps the antimicrobial agent within the distal recess3051 while fluid flows through the lumen 3012. Washout refers topreventing the antimicrobial agent from being washed away from thedistal recess 3051 into the lumen of the female luer while the maleconnector is coupled with the female connector. The proximal trap 3071prevents or minimizes fluid flow within the volume of the proximal trap3071 because there is no through path to the body of the female luerlumen. Therefore, the antimicrobial agent is not readily washed awayfrom the proximal trap 3071.

FIG. 30G is an enlarged cross-sectional view of the distal end of theconnector of FIG. 30F. The proximal trap 3071 has a depth A, and thedistal recess 3051 has a depth B. The proximal trap 3071 has a width C,and the distal tip 3055 has a width D. As used in FIG. 30G, the term“width” indicates a distance measured parallel to the centrallongitudinal axis of the male luer, and the term “depth” indicates adistance measured perpendicular to the central longitudinal axis of themale luer.

In some embodiments, the proximal trap depth A can be greater than orequal to 0.10 mm, 0.15 mm, 0.20 mm, 0.25 mm, 0.30 mm, 0.35 mm, 0.40 mm,or 0.45 mm. In some embodiments, the proximal trap depth A can be lessthan or equal to 0.80 mm, 0.75 mm, 0.70 mm, 0.65 mm, 0.60 mm, 0.55 mm,0.50 mm, or 0.45 mm. In some embodiments, the proximal trap depth A canfall within a range of 0.10 mm to 0.80 mm, or 0.15 mm to 0.75 mm, or0.20 mm to 0.70 mm, or 0.25 mm to 0.65 mm, or 0.30 mm to 0.60 mm, or0.35 mm to 0.55 mm, or 0.40 mm to 0.50 mm, or can be about 0.39 mm.

The distal recess depth B is greater than the proximal trap depth A. Insome embodiments, the distal recess depth B can be greater than or equalto 0.20 mm, 0.26 mm, 0.31 mm, 0.37 mm, 0.42 mm, 0.48 mm, 0.54 mm, 0.59mm, or 0.65 mm. In some embodiments, the distal recess depth B can beless than or equal to 1.00 mm, 0.96 mm, 0.91 mm, 0.87 mm, 0.82 mm, 0.78mm, 0.74 mm, 0.69 mm, or 0.65 mm. In some embodiments, the distal recessdepth B can fall within a range of 0.20 mm to 1.00 mm, or 0.26 mm to0.96 mm, or 0.31 mm to 0.91 mm, or 0.37 mm to 0.87 mm, or 0.42 mm to0.82 mm, or 0.48 mm to 0.78 mm, or 0.54 mm to 0.74 mm, or 0.59 mm to0.69 mm, or can be about 0.77 mm.

The distal recess depth B affects the depth of the cavity formed formedbetween the distal tip surface and the female tapered surface when themale luer is coupled with a female luer. In some embodiments, the distaltip can have an outer diameter that is less than 95 percent of an innerdiameter of the female tapered surface at a point radially outward ofthe distal tip. In some embodiments, the distal tip can have an outerdiameter that is between 50 percent and 95 percent of the inner diameterof the female tapered surface. In some embodiments, the outer diameterof the distal tip expressed as a percentage of the inner diameter of thefemale tapered surface can be greater than or equal to 50%, 55%, 60%,65%, 70%, 75%, or 80% of the inner diameter of the female taperedsurface. In some embodiments, the outer diameter of the distal tipexpressed as a percentage of the inner diameter of the female taperedsurface can be less than or equal to 95%, 90%, 85%, or 80% of the innerdiameter of the female tapered surface. In some embodiments, the outerdiameter of the distal tip expressed as a percentage of the innerdiameter of the female tapered surface can fall within a range of 50% to95%, or 55% to 90%, or 60% to 90%, or 65% to 85%, or 70% to 85%, or 70%to 80%, or 75% to 85%, or can be about 80% of the inner diameter of thefemale tapered surface. Various alternatives are possible based onparticular applications of the technology.

Additionally, in examples where the distal tip includes blades (such asin the example of FIGS. 17A-F), the distal tip outer diameter isvariable around the circumference of the distal tip, and the outerdiameter of the distal tip expressed as a percentage of the innerdiameter of the female tapered surface will likewise be variable.

In examples where the apex of the blade has an outer diameter equal tothe inner diameter of the female tapered surface (such as in the exampleof FIGS. 28A-F), the distal tip can have an outer diameter that variesbetween 50 percent of the inner diameter of the female tapered surfaceand 100 percent of the inner diameter of the female tapered surface.Other examples are possible, and are within the scope of the disclosedtechnology.

In some embodiments, the proximal trap width C can be greater than orequal to 0.10 mm, 0.18 mm, 0.26 mm, 0.34 mm, 0.41 mm, 0.49 mm, 0.57 mm,0.65 mm, 0.73 mm, 0.81 mm, 0.89 mm, 0.96 mm, 1.04 mm, 1.12 mm, or 1.20mm. In some embodiments, the proximal trap width C can be less than orequal to 2.50 mm, 2.41 mm, 2.31 mm, 2.22 mm, 2.13 mm, 2.04 mm, 1.94 mm,1.85 mm, 1.76 mm, 1.66 mm, 1.57 mm, 1.48 mm, 1.39 mm, 1.29 mm, or 1.20mm. In some embodiments, the proximal trap width C can fall within arange of 0.10 mm to 2.50 mm, or 0.18 mm to 2.41 mm, or 0.26 mm to 2.31mm, or 0.34 mm to 2.22 mm, or 0.41 mm to 2.13 mm, or 0.49 mm to 2.04 mm,or 0.57 mm to 1.94 mm, or 0.65 mm to 1.85 mm, or 0.73 mm to 1.76 mm, or0.81 mm to 1.66 mm, or 0.89 mm to 1.57 mm, or 0.96 mm to 1.48 mm, or1.04 mm to 1.39 mm, or 1.12 mm to 1.29 mm, or can be about 0.51 mm.

The distal tip width D may be larger than the proximal trap width C, butcould alternatively be equal to or smaller than the proximal trap widthC. In some embodiments, the distal tip width D can be greater than orequal to 0.10 mm, 0.30 mm, 0.50 mm, 0.70 mm, 0.90 mm, 1.10 mm, 1.30 mm,1.50 mm, 1.70 mm, 1.90 mm, or 2.10 mm. In some embodiments, the distaltip width D can be less than or equal to 4.00 mm, 3.81 mm, 3.62 mm, 3.43mm, 3.24 mm, 3.05 mm, 2.86 mm, 2.67 mm, 2.48 mm, 2.29 mm, or 2.10 mm. Insome embodiments, the distal tip width D can fall within a range of 0.10mm to 4.00 mm, or 0.30 mm to 3.81 mm, or 0.50 mm to 3.62 mm, or 0.70 mmto 3.43 mm, or 0.90 mm to 3.24 mm, or 1.10 mm to 3.05 mm, or 1.30 mm to2.86 mm, or 1.50 mm to 2.67 mm, or 1.70 mm to 2.48 mm, or 1.90 mm to2.29 mm, or can be about 2.41 mm.

The tapered sealing member 3042 has a wall thickness E. In someembodiments, the tapered sealing member wall thickness E can be greaterthan or equal to 0.10 mm, 0.15 mm, 0.20 mm, 0.25 mm, 0.30 mm, 0.35 mm,0.40 mm, or 0.45 mm. In some embodiments, the tapered sealing memberwall thickness E can be less than or equal to 0.80 mm, 0.75 mm, 0.70 mm,0.65 mm, 0.60 mm, 0.55 mm, 0.50 mm, or 0.45 mm. In some embodiments, thetapered sealing member wall thickness E can fall within a range of 0.10mm to 0.80 mm, or 0.15 mm to 0.75 mm, or 0.20 mm to 0.70 mm, or 0.25 mmto 0.65 mm, or 0.30 mm to 0.60 mm, or 0.35 mm to 0.55 mm, or 0.40 mm to0.50 mm, or can be about 0.39 mm.

The lumen 3012 has an inner diameter F. In some embodiments, the lumeninner diameter F can be greater than or equal to 1.00 mm, 1.13 mm, 1.26mm, 1.39 mm, 1.52 mm, or 1.65 mm. In some embodiments, the lumen innerdiameter F can be less than or equal to 2.00 mm, 1.93 mm, 1.86 mm, 1.79mm, 1.72 mm, or 1.65 mm. In some embodiments, the lumen inner diameter Fcan fall within a range of 1.00 mm to 2.00 mm, or 1.13 mm to 1.93 mm, or1.26 mm to 1.86 mm, or 1.39 mm to 1.79 mm, or 1.52 mm to 1.72 mm, or canbe about 1.65 mm.

Male Connector with Plurality of Proximal Cavities (FIGS. 31A-G)

Turning now to FIGS. 31A-G, a male connector 3101 includes a male luer3141. The male luer 3141 comprises a tapered sealing member 3142. Thetapered sealing member 3142 has a frustoconical shape that tapers from alarger outer diameter at the proximal portion of the tapered sealingmember 3142 to a smaller outer diameter at the distal portion of thetapered sealing member near the tapered surface distal edge 3161. Thetapered sealing member 3142 has a tapered sealing surface 3143 that isconfigured to mate with a female luer to create a fluid tight fit. Themale connector 3101 further includes threads 3102 that allow the maleconnector 3101 to couple with a female connector. A lumen 3112 runsthrough the male connector 3101.

The male luer 3141 includes a distal tip 3155 with an end face 3104. Thedistal tip 3155 of the male luer 3141 is recessed from the distal lineof taper of the tapered sealing member 3142. A distal recess 3151 isformed by a recessed portion of the distal tip 3155. The distal tipsurface 3152 of the distal tip 3155 defines an outer diameter that issmaller than the outer diameter of the extension of the tapered sealingsurface 3143.

In some examples, an antimicrobial agent is applied to the distal tipsurface 3152 by coating, spraying, or dipping the distal tip 3155 withan antimicrobial agent, although other methods of applying antimicrobialagent are contemplated and are within the scope of the technology. Insome examples, antimicrobial agent is also applied to the taperedsealing surface 3143. An antimicrobial agent on the distal tip surface3152 of the distal tip 3155 kills microbes within the distal recess 3151between the surface of the female luer and the distal tip surface 3152.The distal recess 3151 is designed to confine the antimicrobial agentbetween the inner surface of a female luer and the distal tip surface3152 so that microbes are exposed to a high antimicrobial concentration.

The distal recess 3151 affects confinement of microbes because thedistal recess 3151 provides a restricted space in which microbes can betrapped between the distal tip surface 3152 and an inside surface of afemale luer. As seen in FIG. 31F, the distal tip 3155 has an outerdiameter that is smaller than the outer diameter of the tapered sealingmember 3142 at the tapered surface distal edge 3161, and the outerdiameter of the distal tip 3155 is smaller than the outer diameter of adistal line of taper defined by the conical tapered sealing member 3142.

Like the example of FIG. 30, the tapered surface distal edge 3161 has atapered surface distal edge face 3162. But the distal tip 3155 includesa plurality of proximal traps 3171 that are isolated from each other byproximal trap walls 3173. The proximal traps 3171 have no separateentrance and exit. Antimicrobial agent can be stored on the surface ofthe proximal trap walls 3173, and the antimicrobial agent will diffuseout of the proximal trap 3171 after the male luer 3141 has beeninstalled inside a female luer.

Male Connector with Blade and Plurality of Proximal Cavities (FIGS.32A-G)

Turning now to FIGS. 32A-G, a male connector 3201 includes a male luer3241. The male luer 3241 comprises a tapered sealing member 3242. Thetapered sealing member 3242 has a frustoconical shape that tapers from alarger outer diameter at the proximal portion of the tapered sealingmember 3242 to a smaller outer diameter at the distal portion of thetapered sealing member near the tapered surface distal edge 3261. Thetapered sealing member 3242 has a tapered sealing surface 3243 that isconfigured to mate with a female luer to create a fluid tight fit. Themale connector 3201 further includes threads 3202 that allow the maleconnector 3201 to couple with a female connector. A lumen 3212 runsthrough the male connector 3201.

The male luer 3241 includes a distal tip 3255 with an end face 3204. Thedistal tip 3255 of the male luer 3241 is recessed from the distal lineof taper of the tapered sealing member 3242. A distal recess 3251 isformed by a recessed portion of the distal tip 3255. The distal tipsurface 3252 of the distal tip 3255 defines an outer diameter that issmaller than the outer diameter of the extension of the tapered sealingsurface 3243.

The male luer 3241 includes a tapered surface distal edge 3261 thatdefines a proximal end of the distal tip 3255. In some examples, anantimicrobial agent is applied to the distal tip surface 3252 bycoating, spraying, or dipping the distal tip 3255 with an antimicrobialagent, although other methods of applying antimicrobial agent arecontemplated and are within the scope of the technology. In someexamples, antimicrobial agent is also applied to the tapered sealingsurface 3243. An antimicrobial agent on the distal tip surface 3252 ofthe distal tip 3255 kills microbes within the distal recess 3251 betweenthe surface of the female luer and the distal tip surface 3252. Thedistal recess 3251 is designed to confine the antimicrobial agentbetween the inner surface of a female luer and the distal tip surface3252 so that microbes are exposed to a high antimicrobial concentration.

The male luer 3241 further includes multiple blades 3263 arrayed aroundthe distal tip 3255 of the male luer 3241. Between the blades 3263 are aplurality of channels 3267. In the example of FIG. 32, the blades 3263are elongated projections arranged around the axis of the taperedsealing member 3242, and the channels 3267 are elongated recessesdisposed between the blades 3263 and running parallel to the lumen 3212.The blades 3263 and channels 3267 form alternating apexes 3264 andtroughs 3268. The distal tip surface 3252 of the distal tip 3255 isdefined by the blades 3263 and channels 3267. An antimicrobial agent onthe distal tip surface 3252 can be stored within the volumes between theblades 3263.

During insertion of the male luer 3241 into a female luer, portions ofthe distal tip 3255 may come in contact with the inside surface of thefemale luer. The apex 3264 of each blade 3263 may come in contact withthe female luer surface, but the troughs 3268 of the channels 3267 willnot come in contact with the female luer surface. Thus, in comparison tothe tapered surface distal edge 3261, the blades 3263 have a relativelysmaller surface area near the end face 3204 of the distal tip 3255. Thisminimizes the amount of ingress of microbes that can be attributed tomicrobes being pushed into the body of the female luer by the male luer3241.

The channels 3267 affect confinement of microbes within the distalrecess because the channels 3267 provide a restricted space in whichmicrobes can be trapped between the distal tip surface 3252 and aninside surface of a female luer. The apex 3264 of the blades 3263provide a maximum outer diameter of the distal tip 3255, and the troughs3268 of the channels 3267 provide a minimum outer diameter of the distaltip 3255. Although some fluid flow between adjacent channels 3267 ispossible when the male luer 3241 is coupled with a female luer, theblades 3263 provide a partial physical barrier. As seen in FIGS. 32E and32F, the distal tip 3255 has an outer diameter that is smaller than theouter diameter of the tapered sealing member 3242 at the tapered surfacedistal edge 3261, and the outer diameter of the distal tip 3255 issmaller than the outer diameter of a distal line of taper defined by theconical tapered sealing member 3242.

The male luer 3241 includes a tapered surface distal edge 3261 having atapered surface distal edge face 3262. Like this example of FIG. 31, aplurality of proximal traps 3271 are formed within a plurality ofproximal trap walls 3273 that are proximal to the tapered surface distaledge face 3262. This can be seen most clearly and FIG. 32G. Eachproximal trap 3271 is isolated from the other proximal traps. Eachproximal trap 3271 has only one entrance and exit, forming a cavitysurrounded by the proximal trap walls 3273 on all sides. The proximaltrap 3271 is defined between the distal tip surface 3252 and theproximal trap walls 3273. The proximal trap 3271 is a cavity that isbounded on multiple sides. The proximal trap 3271 opens on the distalrecess 3251. The proximal trap is adjacent to the tapered surface distaledge face 3262. An antimicrobial agent can be contained inside of theproximal trap 3271.

Male Luer Cap with Blades (FIGS. 33A-F)

Turning now to FIGS. 33A-F, a male luer cap 3301 includes a male luer3341. The male luer 3341 comprises a tapered sealing member 3342. Thetapered sealing member 3342 has a frustoconical shape that tapers from alarger outer diameter at the proximal portion of the tapered sealingmember 3342 to a smaller outer diameter at the distal portion of thetapered sealing member near the tapered surface distal edge 3361. Thetapered sealing member 3342 has a tapered sealing surface 3343 that isconfigured to mate with a female luer to create a fluid tight fit. Themale luer cap 3301 further includes threads 3302 that allow the maleluer cap 3301 to couple with a female connector.

The male luer 3341 includes a distal tip 3355 with an end face 3304. Thedistal tip 3355 of the male luer 3341 is recessed from the distal lineof taper of the tapered sealing member 3342. A distal recess 3351 isformed by a recessed portion of the distal tip 3355. The distal tipsurface 3352 of the distal tip 3355 defines an outer diameter that issmaller than the outer diameter of the extension of the tapered sealingsurface 3343.

The male luer 3341 includes a tapered surface distal edge 3361 thatdefines a proximal end of the distal tip 3355. In some examples, anantimicrobial agent is applied to the distal tip surface 3352 bycoating, spraying, or dipping the distal tip 3355 with an antimicrobialagent, although other methods of applying antimicrobial agent arecontemplated and are within the scope of the technology. In someexamples, antimicrobial agent is also applied to the tapered sealingsurface 3343. An antimicrobial agent on the distal tip surface 3352 ofthe distal tip 3355 kills microbes within the distal recess 3351 betweenthe surface of the female luer and the distal tip surface 3352. Thedistal recess 3351 is designed to confine the antimicrobial agentbetween the inner surface of a female luer and the distal tip surface3352 so that microbes are exposed to a high antimicrobial concentration.

The male luer 3341 further includes multiple blades 3363 arrayed aroundthe distal tip 3355 of the male luer 3341. Between the blades 3363 are aplurality of channels 3367. In the example of FIG. 33, the blades 3363are elongated projections arranged around the axis of the taperedsealing member 3342, and the channels 3367 are elongated recessesdisposed between the blades 3363. The blades 3363 and channels 3367 formalternating apexes 3364 and troughs 3368. The distal tip surface 3352 ofthe distal tip 3355 is defined by the blades 3363 and channels 3367. Anantimicrobial agent on the distal tip surface 3352 can be stored withinthe volumes between the blades 3363.

During insertion of the male luer 3341 into a female luer, portions ofthe distal tip 3355 may come in contact with the inside surface of thefemale luer. The apex 3364 of each blade 3363 may come in contact withthe female luer surface, but the troughs 3368 of the channels 3367 willnot come in contact with the female luer surface. Thus, in comparison tothe tapered surface distal edge 3361, the blades 3363 have a relativelysmaller surface area near the end face 3304 of the distal tip 3355. Thisminimizes the amount of ingress of microbes that can be attributed tomicrobes being pushed into the body of the female luer by the male luer3341.

The channels 3367 affect confinement of microbes within the distalrecess because the channels 3367 provide a restricted space in whichmicrobes can be trapped between the distal tip surface 3352 and aninside surface of a female luer. The apex 3364 of the blades 3363provide a maximum outer diameter of the distal tip 3355, and the troughs3368 of the channels 3367 provide a minimum outer diameter of the distaltip 3355. Although some fluid flow between adjacent channels 3367 ispossible when the male luer 3341 is coupled with a female luer, theblades 3363 provide a partial physical barrier. As seen in FIGS. 33D and33E, the distal tip 3355 has an outer diameter that is smaller than theouter diameter of the tapered sealing member 3342 at the tapered surfacedistal edge 3361, and the outer diameter of the distal tip 3355 issmaller than the outer diameter of a distal line of taper defined by theconical tapered sealing member 3342.

The male luer cap 3301 does not include a lumen, as it is designed toprevent fluid flow out of a medical device having a female luer at theproximal end of the medical device. An antimicrobial agent can coat thedistal tip surface 3352. In some examples, the antimicrobial agent canalso coat the end face 3304. Although not shown in the drawings of FIG.33, the male luer cap 3301 could further include one or more proximaltraps similar to those described above.

Luer Coupler with Blades at Male Distal End (FIGS. 34A-F)

Turning now to FIGS. 34A-F, a luer coupler 3401 includes a maleconnector portion 3449 and a female connector portion 3489 integral withthe male connector portion 3449. A lumen 3412 runs through both thefemale connector portion 3489 and the male connector portion 3449. Thefemale connector portion 3489 of the luer coupler 3401 includes threads3486 for coupling with a male connector. The female connector portion3489 further includes a female luer tapered sealing surface 3488.

The male luer 3441 comprises a tapered sealing member 3442. The taperedsealing member 3442 has a frustoconical shape that tapers from a largerouter diameter at the proximal portion of the tapered sealing member3442 to a smaller outer diameter at the distal portion of the taperedsealing member near the tapered surface distal edge 3461. The taperedsealing member 3442 has a tapered sealing surface 3443 that isconfigured to mate with a female luer to create a fluid tight fit. Theluer coupler 3401 further includes threads 3402 that allow the luercoupler 3401 to couple with a female connector.

The male luer 3441 includes a distal tip 3455 with an end face 3404. Thedistal tip 3455 of the male luer 3441 is recessed from the distal lineof taper of the tapered sealing member 3442. A distal recess 3451 isformed by a recessed portion of the distal tip 3455. The distal tipsurface 3452 of the distal tip 3455 defines an outer diameter that issmaller than the outer diameter of the extension of the tapered sealingsurface 3443.

The male luer 3441 includes a tapered surface distal edge 3461 thatdefines a proximal end of the distal tip 3455. In some examples, anantimicrobial agent is applied to the distal tip surface 3452 bycoating, spraying, or dipping the distal tip 3455 with an antimicrobialagent, although other methods of applying antimicrobial agent arecontemplated and are within the scope of the technology. In someexamples, antimicrobial agent is also applied to the tapered sealingsurface 3443. An antimicrobial agent on the distal tip surface 3452 ofthe distal tip 3455 kills microbes within the distal recess 3451 betweenthe surface of the female luer and the distal tip surface 3452. Thedistal recess 3451 is designed to confine the antimicrobial agentbetween the inner surface of a female luer and the distal tip surface3452 so that microbes are exposed to a high antimicrobial concentration.

The male luer 3441 further includes multiple blades 3463 arrayed aroundthe distal tip 3455 of the male luer 3441. Between the blades 3463 are aplurality of channels 3467. In the example of FIG. 34, the blades 3463are elongated projections arranged around the axis of the taperedsealing member 3442, and the channels 3467 are elongated recessesdisposed between the blades 3463 and running parallel to the lumen 3412.The blades 3463 and channels 3467 form alternating apexes 3464 andtroughs 3468. The distal tip surface 3452 of the distal tip 3455 isdefined by the blades 3463 and channels 3467. An antimicrobial agent onthe distal tip surface 3452 can be stored within the volumes between theblades 3463.

During insertion of the male luer 3441 into a female luer, portions ofthe distal tip 3455 may come in contact with the inside surface of thefemale luer. The apex 3464 of each blade 3463 may come in contact withthe female luer surface, but the troughs 3468 of the channels 3467 willnot come in contact with the female luer surface. Thus, in comparison tothe tapered surface distal edge 3461, the blades 3463 have a relativelysmaller surface area near the end face 3404 of the distal tip 3455. Thisminimizes the amount of ingress of microbes that can be attributed tomicrobes being pushed into the body of the female luer by the male luer3441.

The channels 3467 affect confinement of microbes within the distalrecess because the channels 3467 provide a restricted space in whichmicrobes can be trapped between the distal tip surface 3452 and aninside surface of a female luer. The apex 3464 of the blades 3463provide a maximum outer diameter of the distal tip 3455, and the troughs3468 of the channels 3467 provide a minimum outer diameter of the distaltip 3455. Although some fluid flow between adjacent channels 3467 ispossible when the male luer 3441 is coupled with a female luer, theblades 3463 provide a partial physical barrier. As seen in FIGS. 34C and34D, the distal tip 3455 has an outer diameter that is smaller than theouter diameter of the tapered sealing member 3442 at the tapered surfacedistal edge 3461, and the outer diameter of the distal tip 3455 issmaller than the outer diameter of a distal line of taper defined by theconical tapered sealing member 3442.

Luer Coupler with Proximal Trap at Male Distal End (FIGS. 35A-F)

Turning now to FIGS. 35A-F, a luer coupler 3501 includes a maleconnector portion 3549 and a female connector portion 3589 integral withthe male connector portion 3549. A lumen 3512 runs through both thefemale connector portion 3589 and the male connector portion 3549. Thefemale connector portion 3589 of the luer coupler 3501 includes threads3586 for coupling with a male connector. The female connector portion3589 further includes a female luer tapered sealing surface 3588.

The male luer 3541 comprises a tapered sealing member 3542. The taperedsealing member 3542 has a frustoconical shape that tapers from a largerouter diameter at the proximal portion of the tapered sealing member3542 to a smaller outer diameter at the distal portion of the taperedsealing member near the tapered surface distal edge 3561. The taperedsealing member 3542 has a tapered sealing surface 3543 that isconfigured to mate with a female luer to create a fluid tight fit. Theluer coupler 3501 further includes threads 3502 that allow the luercoupler 3501 to couple with a female connector.

The male luer 3541 includes a distal tip 3555 with an end face 3504. Thedistal tip 3555 of the male luer 3541 is recessed from the distal lineof taper of the tapered sealing member 3542. A distal recess 3551 isformed by a recessed portion of the distal tip 3555. The distal tipsurface 3552 of the distal tip 3555 defines an outer diameter that issmaller than the outer diameter of the extension of the tapered sealingsurface 3543.

The male luer 3541 includes a tapered surface distal edge 3561 thatdefines a proximal end of the distal tip 3555. In some examples, anantimicrobial agent is applied to the distal tip surface 3552 bycoating, spraying, or dipping the distal tip 3555 with an antimicrobialagent, although other methods of applying antimicrobial agent arecontemplated and are within the scope of the technology. In someexamples, antimicrobial agent is also applied to the tapered sealingsurface 3543. An antimicrobial agent on the distal tip surface 3552 ofthe distal tip 3555 kills microbes within the distal recess 3551 betweenthe surface of the female luer and the distal tip surface 3552. Thedistal recess 3551 is designed to confine the antimicrobial agentbetween the inner surface of a female luer and the distal tip surface3552 so that microbes are exposed to a high antimicrobial concentration.

The tapered surface distal edge 3561 has a tapered surface distal edgeface 3562. A proximal trap 3571 is defined between the distal tipsurface 3552 and the proximal trap walls 3573. The proximal trap 3571 isa cavity that is bounded on multiple sides. The proximal trap 3571 openson the distal recess 3551. The proximal trap is adjacent to the taperedsurface distal edge face 3562. As will be discussed below in relation toFIGS. 38 and 39, an antimicrobial agent can be contained inside of theproximal trap 3571.

The proximal trap 3571 stores an antimicrobial agent within the annularcavity defined by the proximal trap 3571. In some examples, microbesreside near the interface between the tapered surface distal edge 3561and a surface of a female luer. The antimicrobial agent stored in theproximal trap 3571 ensures that the concentration of the antimicrobialagent remains high (up to the level of saturation) in the vicinity ofmicrobes.

Both the proximal trap 3571 and the distal recess 3551 are designed tominimize washout of the antimicrobial agent from the volume createdbetween the female luer surface and the distal tip surface 3552. Theproximal trap 3571 has no separate entrance and exit. The antimicrobialagent on the surface of the proximal trap wall 3573 will diffuse out ofthe proximal trap 3571 after the male luer 3541 has been installedinside a female luer. The proximal trap 3571 prevents or minimizes fluidflow within the volume of the proximal trap 3571 because there is nothrough path to the body of the female luer lumen. Therefore, theantimicrobial agent is not readily washed away from the proximal trap3571.

As seen in FIG. 35D, the distal tip 3555 has an outer diameter that issmaller than the outer diameter of the tapered sealing member 3542 atthe tapered surface distal edge 3561, and the outer diameter of thedistal tip 3555 is smaller than the outer diameter of a distal line oftaper defined by the conical tapered sealing member 3542.

Luer Couplers Coupled with Male and Female Luers (FIGS. 36-37)

FIG. 36 shows the luer coupler 3501 coupled between a male connector3611 and a female luer 3691. FIG. 37 shows a luer coupler 3701 coupledbetween the male connector 3611 and the female luer 3691. The maleconnector 3611 has a male luer 3641 and a lumen 3621. The male luer 3641is mated with the female luer tapered sealing surface 3588 of the luercoupler 3501. The female luer 3691 has a female luer tapered sealingsurface 3688 and a lumen 3695.

The luer coupler 3701 is similar to the luer coupler 3501, with similarfeatures and functions. The male connector portion 3749 of the luercoupler 3501 is similar to the male connector 2001 described inconnection with FIGS. 20A-G, described above.

The luer coupler 3701 includes a male connector portion 3749 and afemale connector portion 3789 integral with the male connector portion3749. A lumen 3712 runs through both the female connector portion 3789and the male connector portion 3749. The female connector portion 3789further includes a female luer tapered surface 3788.

The luer coupler 3701 includes a male luer 3741. The male luer 3741comprises a tapered sealing member 3742 with a tapered surface distaledge 3761. The luer coupler 3701 further includes threads 3702 thatallow the luer coupler 3701 to couple with a female connector. A lumen3712 runs through the luer coupler 3701.

The male luer 3741 includes a distal tip 3755 with a distal recess 3751and an end face 3704. The distal tip surface 3752 of the distal tip 3755defines an outer diameter that is smaller than the outer diameter of theextension of the tapered sealing surface 3743. The distal recess 3751forms a cavity once the male luer 3741 is installed into a female luer3691.

The tapered surface distal edge 3761 defines a proximal end of thedistal tip 3755. In some examples, an antimicrobial agent is applied tothe distal tip surface 3752 by coating, spraying, or dipping the distaltip 3755 with an antimicrobial agent, although other methods of applyingantimicrobial agent are contemplated and are within the scope of thetechnology. In some examples, antimicrobial agent is also applied to thetapered sealing surface 3743.

The male luer 3741 further includes multiple blades 3763 arrayed aroundthe distal tip 3755 of the male luer 3741. Between the blades 3763 are aplurality of channels 3767.

Fluid Flow Analysis of Male Connector (FIGS. 38-39)

FIGS. 38-39 are visual representations of mathematical modeling ofsteady-state flow simulations of fluid flowing through a coupled maleand female luer. Without wishing to be bound by theory, these modelssimulate a syringe delivering fluid to the female connector (FIG. 38)and an IV-drip delivery system (FIG. 39). The syringe load ischaracterized as a flow of 2 milliliters/seconds for up to five seconds.The IV drip load is characterized as a flow of 1 liter/hour for up toone hour. The simulation can be applied to systems such as the coupledmale connector portion 3549 and female luer 3691 of FIG. 36.

FIG. 38 shows the operation of the system shown in FIG. 36. In FIG. 38,the male luer 3541 is inserted into the lumen 3695 of the female luer3691. The tapered sealing surface 3543 of the male luer 3541 and thetapered sealing surface 3688 of the female luer 3691 form a male-femaleluer interface with a fluid tight seal. The distal tip 3555 of the maleluer 3541 is set back from the female luer tapered sealing surface 3688.

The male luer 3541 has a distal recess 3551. The male luer 3541 includesa distal tip 3555 having a distal tip surface 3552. A cavity is formedbetween the distal tip surface 3552 and the tapered sealing surface 3688of the female luer 3691. The cavity 3802 is also bounded by a taperedsurface distal edge face 3562 adjacent to tapered surface distal edge3561. In the example of FIG. 38, the male luer 3541 further includes aproximal trap 3571 defined by proximal trap walls 3573.

A fluid passage is defined within the lumen 3512 of the male luer 3541and the lumen 3695 of the female luer 3691. The fluid passage hasmultiple fluid flow regions. A bulk flow region 3801 is the space inwhich fluid travels through the connection of the male and female luers.A cavity 3802 is formed between the distal tip surface 3552 and thefemale luer tapered sealing surface 3688. A boundary region 3803 issituated between the bulk flow region 3801 and the cavity 3802. Aproximal trap region 3804 is situated proximal to the tapered surfacedistal edge face 3562.

The distal tip surface 3552 contains a solid deposit of an antimicrobialagent, referred to as the load. An antimicrobial composition can bedeposited in the proximal trap 3571 and on one or more of the walls,surfaces or faces of the female connector. The distal tip surface 3552can be the predominant location at which surface-bound microbes arepresent within the luer connection.

The cavity 3802 confines recirculation of fluids while a fluid loadpasses through the luer connection. The antimicrobial compositiondisperses into the fluidic recirculation. The recirculating fluid withinthe cavity 3802 recirculates the antimicrobial composition, whichincreases the antimicrobial concentration within this region anddistributes the antimicrobial agent onto the inner surface of the femaleconnector. The presence of antimicrobial agent along the inner surfaceof the female connector within the cavity 3802 prevents microbes locatedat the male-female interface from propagating along the wall of thefemale luer tapered sealing surface 3688.

Fluid flow through the design generates a set of three fluidicrecirculations, or vortexes. These vortexes create a fluidic boundarybetween passing fluid and a microbial load located at the male-femaleinterface edge. The three vortices can be described by their location. Aproximal trap vortex contained in the proximal trap 3571 contains alarge antimicrobial load. The cavity vortex is located adjacent to theproximal trap vortex. A boundary vortex is sandwiched between the cavityvortex and the stream of fluid passing through the bulk flow region3801.

In the example of FIG. 38, vortexes are created in the boundary region3803, the cavity 3802, and the proximal trap region 3804. Antimicrobialagent is contained and recirculated within each of these regions. Insome examples, the proximal trap region 3804 contains a load ofantimicrobial agent that is greater than can be dissolved into thecavity 3802 at saturation concentration; thus the proximal trap 3571serves as an antimicrobial agent reservoir to maintain a highantimicrobial concentration. In some examples, the antimicrobialconcentration can be around 200 micrograms per milliliter (μg/ml) ofchlorhexidine.

FIG. 39 shows the operation of the system shown in FIG. 36, as describedabove, under IV drip conditions. A bulk flow region 3901 is the space inwhich fluid travels through the connection of the male and female luers.A cavity 3902 is formed between the distal tip surface 3552 and thefemale luer tapered sealing surface 3688. A boundary region 3903 issituated between the bulk flow region 3901 and the recess region. Aproximal trap region 3904 is situated proximal to the tapered surfacedistal edge face 3562.

In the example of FIG. 39, vortexes are created in the boundary region3903, the cavity 3902, and the proximal trap region 3904. Antimicrobialagent is contained and recirculated within each of these regions.

We claim:
 1. A needleless connector comprising: a male connector havinga male tapered surface, the male connector further including: i) adistal tip having a distal end; ii) the distal tip having a recesssurface proximal to the distal end, wherein the recess surface isradially inward of a line of taper extending along, and distal of, themale tapered surface at a first taper angle relative to a centrallongitudinal axis of the male connector; and iii) a water-solubleantimicrobial composition positioned on the recess surface.
 2. Theneedleless connector of claim 1, the male connector further comprising atapered surface distal edge proximal to the distal tip of the maleconnector, the tapered surface distal edge being at a distalmost end ofthe male tapered surface.
 3. The needleless connector of claim 2,wherein the tapered surface distal edge is proximal to at least part ofa recess defined by the recess surface of the male connector.
 4. Theneedleless connector of claim 2, wherein the distal tip has a proximaledge abutting the tapered surface distal edge, wherein the taperedsurface distal edge has an outer diameter, the proximal edge of thedistal tip has an outer diameter, and the outer diameter of the taperedsurface distal edge is greater than the outer diameter of the proximaledge of the distal tip.
 5. The needleless connector of claim 2, whereinthe tapered surface distal edge defines a portion of the recess.
 6. Theneedleless connector of claim 1, further comprising a fluid flow channelthrough the male connector.
 7. The needleless connector of claim 1,wherein the antimicrobial composition comprises chlorhexidine.
 8. Theneedleless connector of claim 1, wherein a plurality of blades extendradially outward from the recess surface.
 9. The needleless connector ofclaim 8, wherein the plurality of blades have a plurality of bladesurfaces.
 10. The needleless connector of claim 9, wherein the bladesurfaces contain at least a portion of the water-soluble antimicrobialcomposition.
 11. The needleless connector of claim 8, wherein the bladesare arranged substantially parallel to the central longitudinal axis.12. The needleless connector of claim 1, wherein the first taper angleis equal to a second taper angle of the recess surface relative to thecentral longitudinal axis.
 13. The needleless connector of claim 1,wherein the distal tip defines a recess, the device further comprising aproximal trap comprising a cavity at least partially opening into therecess.
 14. The needleless connector of claim 13, wherein at least aportion of the water-soluble antimicrobial composition is containedwithin the proximal trap.
 15. A needleless connector comprising: a maleconnector having a male tapered surface configured to engage a femaleconnector, the female connector having a female tapered surface, suchthat the male tapered surface engages the female tapered surface to forma fluid-tight seal, the male connector further including: i) a conicaltaper defined in part by the male tapered surface; ii) a distal tiphaving a recess surface proximal to a distal end of the male connector,the recess surface residing inside the conical taper; iii) a taperedsurface distal edge proximal to the distal tip, the tapered surfacedistal edge having an outer diameter greater than the outer diameter ofthe distal tip; iv) a fluid flow channel through the male connector; andv) a water-soluble antimicrobial composition positioned on the recesssurface; wherein upon insertion of the male connector into the femaleconnector, an annular cavity is formed between the recess surface andthe female tapered surface of the female connector.
 16. The needlelessconnector of claim 15, wherein the device is configured such that theannular cavity defines an annular volume between the male connector andthe female connector, and wherein a portion of the antimicrobialcomposition is dissolvable into a fluid to form a chlorhexidineprecipitate on a portion of the female tapered surface.
 17. Theneedleless connector of claim 15, wherein a plurality of blades extendradially outward from the recess surface into the annular cavity to atleast partially divide the annular cavity.
 18. A needleless connectorfor delivering an antimicrobial composition into an infusion device, thedevice comprising: a male connector having a male tapered surfaceconfigured to insert into a female connector of an infusion device, thefemale connector having a female tapered surface, such that the maletapered surface engages the female tapered surface to form a fluid-tightseal, the male connector having: i) a conical taper defined in part bythe male tapered surface; ii) a distal tip having an outer diameter thatis less than 95 percent of an inner diameter of the female taperedsurface at a point radially outward of the distal tip; iii) a recesssurface proximal to the distal tip and inside the conical taper; iv) afluid flow channel through the male connector; v) a water-solubleantimicrobial composition positioned on the recess surface; wherein,upon insertion of the male connector into the female connector, anannular cavity is formed between the recess surface and the femaletapered surface of the female connector, the annular cavity having aproximal end and a distal end, a volume between the proximal end and thedistal end, a width measured radially, and a length measured axially;wherein the male tapered surface has a distal edge that at leastpartially defines the proximal end of the annular cavity, the distal endof the annular cavity is in fluid communication with a fluid lumen ofthe infusion device, and the width of the annular cavity is less than 50percent of the length of the annular cavity; and wherein a fluid insidethe infusion device at least partially fills the annular cavity, and atleast a portion of the antimicrobial composition is dispersed within thefluid in the annular cavity.
 19. The needleless connector of claim 18,wherein the distal tip defines a recess, the device further comprising aproximal trap comprising a cavity at least partially opening into therecess.
 20. The needleless connector of claim 18, wherein a plurality ofblades extend radially outward from the recess surface into the annularcavity to at least partially divide the annular cavity.